Qureos Mentor

Syneos Health

<div>Description
Sr Biostatistician Oncology (North America Only)
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>-Must be located in NA without sponsorship needs. Remote in North America.</li></ul><div>
Education: MS required, PhD preferred 
TA: Oncology is expected 
Phase experience: Pre-clinical, Phase I-IIab 
PK/PD is a nice to have 
Lead experience is a plus 
<ul><li>Interacting with the team</li><li>Directing the work of others</li><li>Able to quickly adapt and deliver</li></ul>
Study design experience: BOIN, since that is what most of them are 
Endpoints: mainly overall response, PFS as secondary, some biomarkers 
Additional expectations: 
<ul><li>Running simulations and supporting design alternatives</li><li>Output review</li><li>Familiarity with SDTM/ADaM datasets (not programming them, just using them for output review, knowing which ones are for what)</li><li>IB authoring, DSUR reviews</li></ul></div><h3 class="jobSectionHeader">
JOB SUMMARY</h3><h3 class="jobSectionHeader">
This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects.
</h3><h3 class="jobSectionHeader">JOB RESPONSIBILITIES</h3><ul><li>
Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.</li><li>
Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.</li><li>
May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.</li><li>
Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.</li><li>
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.</li><li>
Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.</li><li>
Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.</li><li>
Implements company objectives, and create alternative solutions to address business and operational challenges.</li><li>
Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.</li><li>
Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.</li><li>
Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management.</li><li>
Provides statistical programming support as needed.</li><li>
May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.</li><li>
May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.</li><li>
Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).</li><li>
Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.</li><li>
Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.</li><li>
Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.</li><li>
Coaches and mentors other Biostatistics staff.</li><li>
Performs other work-related duties as assigned.</li><li>
Minimal travel may be required.</li></ul>
QUALIFICATION REQUIREMENTS<ul><li>
Graduate degree in biostatistics or related discipline.</li><li>
Moderate experience in clinical trials or an equivalent combination of education and experience.</li><li>
Proficiency in programming.</li><li>
Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.</li><li>
Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.</li></ul><ul><li>
Excellent written and verbal communication skills.</li><li>
Ability to read, write, speak, and understand English.</li></ul>
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Education: MS required, PhD preferredTA: Oncology is expectedPhase experience: Pre-clinical, Phase I-IIabPK/PD is a nice to haveLead experience is a plus&bull;Interacting with the team&bull;Directing the work of others&bull;Able to quickly adapt and deliverStudy design experience: BOIN, since that is what most of them areEndpoints: mainly overall response, PFS as secondary, some biomarkersAdditional expectations:&bull;Running simulations and supporting design alternatives&bull;Output review&bull;Familiarity with SDTM/ADaM datasets (not programming them, just using them for output review, knowing which ones are for what)&bull;IB authoring, DSUR reviews</div>

Sr Biostatistician Oncology (North America Only)

<div>Description
Site Management Associate &ndash; Real World Evidence (US - Remote)
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<h1 class="jobSectionHeader">
Site Management Associate &ndash; Real World Evidence (RWE)</h1>
Location: Remote U.S. (East Coast preferred)
Are you a proactive, self‑driven CRA looking to broaden your impact in Real World Evidence (RWE) research? Do you thrive in collaborative teams where your voice is heard and your growth truly matters?
Our RWE team at Syneos Health is expanding&mdash;and we&rsquo;re seeking an experienced Site Management Associate to join our highly cohesive, supportive group. This is an exciting opportunity to work across diverse therapeutic areas, while shaping real-world insights that influence patient care and clinical decision‑making. 
Why This Role Is Different
✔ Collaborative RWE team with strong cross‑functional partnerships
✔ Opportunities for long‑term career growth, professional development, and mentorship
✔ Diverse site exposure &ndash; sites span across the U.S. (not regionally based)
✔ Hands-on monitoring: both on‑site and remote,
✔ High-impact RWE and Late Phase studies that allow you to broaden your expertise
What You&rsquo;ll Do
As a Site Management Associate, you&rsquo;ll be the primary point of contact for assigned sites, supporting the full study lifecycle&mdash;from site identification through closeout. You&rsquo;ll play a critical role in ensuring high‑quality data, strong site engagement, and efficient study execution.
Core Responsibilities:<ul><li>
Conduct site management activities in alignment with Syneos Health and Sponsor SOPs/WIs</li><li>
Ensure study compliance with relevant regulations (ICH-GCP, GPP, RWE guidelines)</li><li>
Manage all monitoring activities (on-site &amp; remote) across study stages</li><li>
Oversee site identification, qualification, start-up, and ongoing support</li><li>
Maintain and reconcile ISF/TMF completeness and accuracy</li><li>
Support subject recruitment, data quality, and query resolution</li><li>
Provide exceptional customer service and training to site staff</li><li>
Maintain clear, timely documentation (trip reports, follow-up letters, logs, etc.)</li><li>
Ensure site audit readiness and support audit preparation</li><li>
Collaborate closely with internal teams, sponsor contacts, and site personnel</li><li>
Manage site-level timelines, communication, and deliverables</li><li>
Present in Investigator Meetings and contribute to team discussions</li></ul> 
What We&rsquo;re Looking For
To succeed in this role, we&rsquo;re seeking someone who is resourceful, organized, and solutions‑oriented&mdash;someone who naturally takes initiative and maintains strong relationships with sites and teams.
Required Qualifications<ul><li>
Minimum 2+ years of CRA experience within a CRO.</li><li>
Demonstrated experience with both in-house &amp; field monitoring</li><li>
BA/BS in a science/healthcare field or nursing degree (or equivalent experience)</li><li>
Proficiency with CTMS, and EDC platforms</li><li>
Excellent communication, organization, and customer-service skills</li><li>
Ability to manage multiple studies simultaneously and adapt to changing priorities</li><li>
Ability to travel up to 60%</li></ul>
Preferred Experience<ul><li>
Previous in‑house site management experience</li></ul>
Who You Are
You&rsquo;ll thrive in this role if you are:<ul><li>
Proactive and self‑motivated, with strong initiative</li><li>
Collaborative and enjoy working in close-knit teams</li><li>
Detail‑oriented, with a passion for high‑quality documentation</li><li>
Flexible and comfortable managing shifting priorities</li><li>
Someone who loves building trusted relationships with sites</li></ul>
If you're looking for a role where your expertise is valued, your development is a priority, and you can make a meaningful impact in RWE research, we&rsquo;d love to connect with you.
Join us&mdash;and help shape the future of real-world clinical research.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$70,100.00 - $126,100.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Site monitor requiring remote and on-site activities in US.</div>

Site Management Associate – Real World Evidence (US - Remote)

<div>Description
Proposal Specialist (Entry-Level/Remote-USA)
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life&reg;.
Discover what our 29,000 employees, across 110 countries already know.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<h1 class="jobSectionHeader">
Proposal Specialist (Entry-Level/Remote-USA)</h1> 
Are you detail-oriented, curious, and ready to begin a meaningful career? We're looking for someone early in their professional journey who is eager to learn and contribute to a collaborative team that plays a key role in developing proposals for clinical research and pharmaceutical services.
This position is well suited for a recent graduate or someone with a bit of relevant experience who is interested in gaining practical exposure to the proposal process, project coordination, and the clinical research industry. You don&rsquo;t need to come in as an expert &mdash; we&rsquo;ll provide training, mentorship, and the support you need to build your skills.<h2 class="jobSectionHeader">
What You&rsquo;ll Do:</h2>
As a Proposal Specialist, you&rsquo;ll support our Global Proposal Management team by helping organize information, maintain internal systems, and keep things running smoothly behind the scenes. You&rsquo;ll also have the opportunity to learn how we review and respond to Requests for Proposals (RFPs) and Requests for Information (RFIs) from clients.
Your responsibilities may include:<ul><li>
Assisting team members with questions about proposal processes and tools</li><li>
Reviewing new RFPs and routing them to the appropriate proposal team, with guidance from your manager or senior colleagues</li><li>
Sending out internal notifications about new assignments</li><li>
Creating digital project folders (SharePoint sites) and uploading essential documents</li><li>
Entering and updating information in our CRM system (Salesforce) and internal workload reports</li><li>
Uploading team reports to SharePoint and helping track daily activity summaries</li><li>
Contributing to database maintenance and data cleanup projects</li><li>
Running basic data queries and reports, as requested</li></ul>
As you grow in the role, you&rsquo;ll gain insight into how we scope and budget our services, interact with different departments, and communicate with clients through well-developed proposals.<h2 class="jobSectionHeader">
What We&rsquo;re Looking For:</h2>
We&rsquo;re looking for someone who is eager to learn and excited to be part of a close-knit, collaborative, detail-focused team. Specifically, we&rsquo;re seeking someone who has:<ul><li>
A bachelor&rsquo;s degree (ideally in business, life sciences, or a related field) &mdash; this is a requirement for the role</li><li>
Familiarity with Microsoft Office tools, especially Word and Excel</li><li>
A high level of attention to detail and accuracy</li><li>
Strong written and verbal communication skills</li><li>
A genuine curiosity about how our business works and a willingness to ask questions</li><li>
A positive, team-oriented approach and the ability to work cooperatively with others</li><li>
A focus on openness, honesty, and follow-through in day-to-day interactions</li><li>
An interest in proposal development and a desire to understand how we scope and communicate our services</li><li>
Comfort managing several small tasks or projects at once and staying organized</li></ul>
Some prior exposure to the clinical research or pharmaceutical industry is helpful but not required. We value potential and attitude just as much as experience.<h2 class="jobSectionHeader">
Why Join Us?:</h2>
This role offers the chance to start your career in a supportive and professional environment where your work has real impact. You&rsquo;ll be part of a close-knit team that values communication, collaboration, and learning. Whether you&rsquo;re organizing project details, maintaining data, or helping the team respond to new opportunities, your contributions will help shape the proposals that drive our business forward.
If you&rsquo;re organized, curious, and ready to grow &mdash; especially in a role where proposal work plays a central part &mdash; we&rsquo;d love to hear from you!
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. 
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Under the supervision of the Director or Manager, this position performs confidential administrative duties and provides support to the Global Proposal &amp; RFI team.</div>

Proposal Specialist (Entry-Level/Remote-USA)

<div>Description
Project Manager I &ndash; Cell &amp; Gene Therapy (Sponsor-Dedicated/ Hybrid- Los Angeles))
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities
Project Manager I &ndash; Sponsor Dedicated (Cell &amp; Gene Therapy)
Location: strongly prefer candidates located near our sponsor&rsquo;s Los Angeles office (near Westwood neighborhood/ UCLA campus)
Role Summary
We are seeking a skilled and motivated Project Manager I to join our sponsor-dedicated team supporting high-impact oncology and cell &amp; gene therapy trials, including CAR-T studies. In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO&mdash;offering the best of both worlds: sponsor collaboration and CRO resources.
This position focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. While remote work is supported, we strongly prefer candidates located near our sponsor&rsquo;s Los Angeles office (near Westwood neighborhood/ UCLA campus) to allow for periodic in-office collaboration and faster integration with the sponsor team.
What You Will Do<ul><li>
Act as a sponsor-facing project manager, ensuring the successful execution of assigned CAR-T and gene therapy trials from startup through closeout.</li><li>
Lead or support study start-up, site activation, and enrollment, working closely with site monitors, regulatory teams, and contracts personnel.</li><li>
Serve as a key point of contact across internal (CRO) and sponsor teams, facilitating regular communications, status reporting, and governance updates.</li><li>
Coordinate with cross-functional stakeholders to ensure timelines, budgets, and milestones are met, particularly in complex, high-touch studies.</li><li>
Track and manage protocol compliance, CAPAs, and site-level quality indicators; support resolution of audit findings.</li><li>
Ensure inspection readiness and regulatory compliance by overseeing TMF maintenance, data accuracy, and documentation completeness.</li><li>
Manage or contribute to the tracking of low-stability endpoint samples and IP-related processes, ensuring timely lab delivery and site support.</li><li>
Assist with risk identification and mitigation planning, while continuously optimizing trial execution processes.</li></ul>
Skills and Experience You Have<ul><li>
2&ndash;4 years of clinical trial experience, preferably in a CRO setting, with a focus on oncology, rare disease, or gene-modified cell therapy trials.</li><li>
Prior involvement in CAR-T or other cell therapy studies is highly desirable.</li><li>
Strong familiarity with GCP/ICH guidelines, FDA/EMA regulations, and inspection-readiness standards.</li><li>
Experience working in sponsor-dedicated or embedded roles within a CRO is a plus.</li><li>
Proficiency in clinical systems (e.g., CTMS, EDC, eTMF) and project management tools.</li><li>
Confident in leading sponsor calls, presenting KPIs, and contributing to operational governance.</li><li>
Bachelor&rsquo;s degree in a relevant field (Life Sciences, Nursing, Pharmacy, etc.) or equivalent work experience.</li><li>
Comfortable with remote work but agreeable to occasional in-person collaboration in Los Angeles.</li></ul>
Why You Want to Work Here<ul><li>
Work sponsor-side, stay CRO-strong: This sponsor-dedicated role offers the visibility and strategic engagement of working directly with a biotech leader, while maintaining CRO support and infrastructure.</li><li>
Advance life-saving research: Be a part of cutting-edge cell and gene therapy trials, helping bring breakthrough therapies to patients faster.</li><li>
Grow your career intentionally: Gain exposure to high-impact projects with opportunities to step up into larger roles and leadership paths.</li><li>
Collaborate where it counts: Enjoy the flexibility of remote work with access to in-office opportunities that foster deeper team integration and mentorship.</li><li>
Be mission-aligned: Work with a team that shares your urgency, attention to detail, and dedication to patients battling cancer and rare diseases.</li></ul>
Why Join Us?
This role offers the opportunity to do more than manage clinical trials &mdash; it&rsquo;s a chance to be at the center of some of the most promising therapeutic advancements in the world. You&rsquo;ll play a critical role in accelerating the development of treatments that could change patients&rsquo; lives forever.
If you're looking to grow your career while making a real-world impact, we invite you to apply and join a mission that matters.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$80,600.00 - $145,000.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
We are seeking a skilled and motivated Project Manager I to join our sponsor-dedicated team supporting high-impact oncology and cell &amp; gene therapy trials, including CAR-T studies. In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO&mdash;offering the best of both worlds: sponsor collaboration and CRO resources.This position focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. While remote work is supported, we strongly prefer candidates located near our sponsor&rsquo;s Los Angeles office to allow for periodic in-office collaboration and faster integration with the sponsor team.</div>

Project Manager I – Cell & Gene Therapy (Sponsor-Dedicated/ Hybrid- Los Angeles))

<div>Description
Clinical Research Associate II
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li><li>
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection 
Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.</li></ul>
Qualifications:<ul><li>
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills</li><li>
Ability to manage required travel of up to 75% on a regular basis</li><li>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</li></ul>
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div>

Clinical Research Associate II

Join Syneos Health and explore 6   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Syneos Health

About Company

Sr Biostatistician Oncology (North America Only)

Site Management Associate – Real World Evidence (US - Remote)

Proposal Specialist (Entry-Level/Remote-USA)

Project Manager I – Cell & Gene Therapy (Sponsor-Dedicated/ Hybrid- Los Angeles))

Project Manager I – Cell & Gene Therapy (Sponsor-Dedicated/ Hybrid- Los Angeles))

Clinical Research Associate II