Qureos Mentor

Syneos Health

<div>Description
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
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
Provides support for all electronic and/or paper Trial Master File (TMF) management activities for assigned projects from award to final transfer. Assigned projects will generally consist of Low to Medium complexity projects. Drives and oversees successful completion of all scoped deliverables for TMF Operations including TMF Plan development, monitoring document submissions and processing, oversight and coordination of Quality Control (QC) processes, internal and external project-specific audit representation, TMF transfers, etc. Involved in monthly project reviews evaluating operational and financial Key Performance Indicators. May support TMF Lead II or Senior TMF Lead for high complexity projects.</div>

Trial Master File (TMF) Lead

<div>Description
Senior Clinical Programmer (Veeva CDB)
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>
Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. 
Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports..</li><li>
Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.</li><li>
Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports</li><li>
Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions.</li><li>
Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with inprogress audits.</li><li>
Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders.</li><li>
Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed.</li><li>
Performs system integration activities, application updates, and user acceptance testing.</li><li>
Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs.</li><li>
Assists in project meetings and actively contributes and participates in departmental review meetings. Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies.</li><li>
Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements.</li><li>
Manages project resources, proactively alerting management of delivery and resourcing needs.</li><li>
Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree preferred, or equivalent combination of related education and experience.</li><li>
Looking for Veeva CDB (Clinical Database) resource at Senior / Principal Role.</li><li>
This resource would be within Administration for Veeva as an SME.</li><li>
Veeva CDB is additional Data acquisition model, so a person should have strong Data Acquisition experience with technical expertise in Veeva CDB, working with External Vendor, experience with Data Transfer Agreements (DTA), Data Import Agreements, Data Mapping, and having SAS experience would be added advantage.</li><li>
Veeva CDB is an exclusive model used for report generation and analytics outcome from EDC.</li><li>
Alternate to CDB Programmer is that we look for base experience in EDC programming willing to move into this role as CDB programmer, have exposure to CDB/Data Acquisition.</li><li>
Must be strong in communication, experience in mentoring, have strong data acquisition experience into CDB</li><li>
Required years of experience &ndash; 2 years in CDB or Overall 5+ years of Data Acquisition, Data Import, Program writing, DTA, DTS experience.</li><li>
Ability to deal effectively with sponsors and internal customers at all levels.</li><li>
Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.</li><li>
Demonstrated experience in managing multiple priorities in a highly dynamic environment</li><li>
Experience working in a matrix-structured environment is preferred</li><li>
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail</li><li>
Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.</li><li>
Ability to travel as necessary (up to 25%)</li></ul>
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 Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.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. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Senior Clinical Programmer (Veeva CDB)

<div>Description
Senior CDS Project Manager
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<h2 class="jobSectionHeader">
JOB SUMMARY</h2>
Ensures the contracted services and expectations of a clinical project are carried out by the Company project team in accordance with the executed contract and the Customer&rsquo;s expectations. Works in the role of a project manager on assigned project(s), which may range from single CDS projects to large full scope CDS projects. Duties include primary liaison with Customers, Clinical team, Vendors, Functional leads, and Senior Management. Acts as a mentor to other CDS (Clinical Development Services) Project Managers.<ul><li>Note CDS (Clinical Development Services) may also be known as &lsquo;Biometrics&rsquo; (i.e. Data Management, Statistics, Statistical Programming, and Medical Writing)</li></ul><h2 class="jobSectionHeader">
JOB RESPONSIBILITIES</h2><ul><li>
Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer&rsquo;s and Company&rsquo;s contractual agreement. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.</li><li>
Serves as the team leader by overseeing the Biometrics project team. Facilitates team building and communication. Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues. Proactively monitors project resources and works with functional lead/management to ensure project requirements are met.</li><li>
Manages multiple projects ranging in size and complexity from single service Biometrics projects to large full scope Biometrics projects, global projects and/or programs, with minimal interaction from supervisor. This includes proactive operational and financial management of tasks, risk, escalations and quality through start-up through final deliverable.</li><li>
Manages the executed contract and financial aspects of assigned projects/programs. Completes periodic review of tasks completed and backlog. Ensures customers are notified of out-of-scope items in a timely manner.</li><li>
Works with internal teams like finance, accounts, contracts to ensure effective financial, contractual and invoice management and issue resolution.</li><li>
Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication.</li><li>
Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery</li><li>
Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management.</li><li>
Networks to acquire new and/or repeat business.</li><li>
Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities as needed. Works with this team and department leads to develop budgets and scope of work for the final contract as needed.</li><li>
Initiates or collaborates with internal teams/clients on process improvements, new processes or any specific initiatives as needed.</li></ul><h2 class="jobSectionHeader">
QUALIFICATION REQUIREMENTS</h2><ul><li>
BA/BS in life sciences, communications, nursing, or equivalent related education and experience.</li><li>
7 to 8+ years of Industry experience (preferably from PM in clinical data science/Biometrics background), able to handle independently.</li><li>
Preferrable to have experience in leading projects &amp; deliverables across function CDM, MW, Biostats, Stats Prog, etc.</li><li>
Responsible for managing project finances (Budget, Revenue Recognition), Contracts, Invoicing, Timeline planning (e.g. Microsoft Project), Risk assessment.</li><li>
Leading a Biometrics/Clinical Data Science Project team and liaising with Clinical Team, Vendors &amp; Clients.</li><li>
Project management experience in a contract research organization, pharmaceutical, or Biotechnology Company preferred.</li><li>
Experience actively managing clinical research projects across CDS functional areas.</li><li>
Previous CRO experience and specific CDS management experience.</li><li>
Other relevant experience preferred.</li><li>
Thorough knowledge of major HA (e.g. FDA, EMEA, PMDA) regulations, drug development, and project management procedures.</li><li>
Demonstrated proficiency with ICH/GCP guidelines.</li><li>
Excellent communication skills.</li><li>
Strong presentation, documentation, and interpersonal (emphasis on proactive leadership) skills as well as a team-oriented approach.</li><li>
Proficient computer skills in Word, Excel, PowerPoint, MS Project, email and internet.</li><li>
Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.</li><li>
High level of competence in English language.</li><li>
Ability to travel up to 25%.</li></ul>
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
Ensures the contracted services and expectations of a clinical project are carried out by the Company project team in accordance with the executed contract and the Customer&rsquo;s expectations. Works in the role of a project manager on assigned project(s), which may range from single CDS projects to large full scope CDS projects. Duties include primary liaison with Customers, Clinical team, Vendors, Functional leads, and Senior Management. Acts as a mentor to other CDS Project Managers.* Note CDS may also be known as &lsquo;Biometrics&rsquo; (i.e. Data Management, Statistics, Statistical Programming, and Medical Writing)</div>

Senior CDS Project Manager

<div>
 
 Description
 
 
 
 Safety &amp; PV Specialist II (Literature Review)
 
 
 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
 
 
 
 
 JOB RESPONSIBILITIES
 
 
 
 <ul>
 <li>
 Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
 </li>
 <li>
 Skilled in extracting and summarizing key safety information from identified literature sources
 </li>
 <li>
 Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.
 </li>
 <li>
 In depth knowledge of major literature databases such as Embase, PubMed etc.
 </li>
 <li>
 Experience in conducting local literature searches and reviews.
 </li>
 <li>
 Understanding of regulatory requirements with respect to global and local literature.
 </li>
 <li>
 Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
 </li>
 <li>
 May assist in the preparation of the Safety Management Plan
 </li>
 <li>
 Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
 </li>
 <li>
 Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
 </li>
 <li>
 Enters data into safety database.
 </li>
 <li>
 Codes events, medical history, concomitant medications and tests.
 </li>
 <li>
 Compiles complete narrative summaries.
 </li>
 <li>
 Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
 </li>
 <li>
 Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
 </li>
 <li>
 Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.
 </li>
 <li>
 Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
 </li>
 <li>
 Participate in audits/inspections as required
 </li>
 <li>
 Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
 </li>
 <li>
 Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.
 
 
 </li>
 </ul>
 Good communication and interpersonal skills, both written and spoken
 
 
 Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
 
 
 
 What We&rsquo;re Looking For
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s Degree, Postgraduate in health profession with relevant experience, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
 </li>
 <li>
 At least 3+ years of experience in Pharmacovigilance, Literature case reviewing (Global+Local), Identifying NICR (Signal &amp; AR) report from Literature.
 </li>
 <li>
 Mandatory to have GVP Module 6 knowledge
 </li>
 <li>
 Safety Database systems and knowledge of medical terminology required
 </li>
 <li>
 Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
 </li>
 <li>
 Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
 </li>
 <li>
 Ability to work independently and in a team environment
 </li>
 <li>
 Good communication and interpersonal skills, both written and spoken
 </li>
 <li>
 Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
 </li>
 <li>
 Detail oriented with a high degree of accuracy and ability to meet deadlines
 </li>
 <li>
 Minimal travel may be required (up to 5%)
 
 
 </li>
 </ul>
 
 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
 
 
 
 Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.
</div>

Safety & PV Specialist II (Literature Review)

<div>Description
Principal Biostatistician
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
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.</div>

Principal Biostatistician

<div>Description
Clinical Project Manager II &ndash; Biomarker Study Management (Sponsor-Dedicated | 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<h2 class="jobSectionHeader">
Clinical Project Manager II &ndash; Biomarker Study Management 
(Sponsor-Dedicated | Remote)</h2>
We&rsquo;re hiring a Clinical Project Manager II with a strong background in biomarker study operations to join our sponsor-dedicated team. This fully remote role gives you the opportunity to drive the success of global clinical trials by leading biomarker and bioanalytical strategy from start to finish.
You'll be a key player in bringing together cross-functional teams, vendors, and internal stakeholders to ensure biological samples are collected, managed, and analyzed to the highest standards.
What You&rsquo;ll Do:
Lead Biomarker Study Operations<ul><li>
Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs</li><li>
Serve as the operational point of contact for all biomarker-related processes</li><li>
Work closely with clinical study teams (Phases 1&ndash;4) to integrate biomarker strategies into broader clinical development plans</li><li>
Plan and manage the collection, tracking, and analysis of biological specimens</li><li>
Advise study teams on best practices for sample management and logistics</li></ul>
Drive Clinical Project Delivery<ul><li>
Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout</li><li>
Ensure studies stay on track with respect to timelines, budget, scope, and quality</li><li>
Act as the main liaison between the sponsor and study partners</li><li>
Monitor and manage project financials, ensuring fiscal responsibility</li><li>
Proactively identify and resolve operational issues and risks</li></ul>
Ensure Operational Excellence<ul><li>
Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness</li><li>
Keep study systems and databases current and audit-ready</li><li>
Prepare project reports and updates for sponsors and internal stakeholders</li><li>
Plan and facilitate internal and external meetings</li><li>
Support inspection readiness and regulatory compliance throughout the project</li></ul><h2 class="jobSectionHeader">
Skills and Experience You Bring:</h2><ul><li>
Significant experience managing biomarker studies and external vendors required!</li><li>
Strong understanding of biomarker and bioanalytical strategies in a clinical trial setting</li><li>
Proven ability to coordinate complex sample collection and analysis workflows</li><li>
Expertise in supporting study teams with sample logistics and operational planning</li><li>
Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience</li><li>
Experience in a clinical research organization (CRO) or sponsor environment preferred</li><li>
Familiarity with GCP, ICH guidelines, and global regulatory standards</li><li>
Strong project management, organizational, and communication skills</li><li>
Comfortable working independently and embracing new technologies</li><li>
Willingness to travel up to 25% as needed</li></ul><h2 class="jobSectionHeader">
Why Join Us:</h2><ul><li>
Meaningful Work: Your contributions will directly support critical biomarker research that shapes the future of clinical development and precision medicine.</li><li>
Global Impact: You'll be working on high-profile studies that span multiple regions, making a real difference in patients&rsquo; lives around the world.</li><li>
Dedicated Team: Join a collaborative, sponsor-dedicated environment where your expertise is trusted, and your voice matters.</li><li>
Flexibility: Enjoy the freedom of a fully remote role with the support of a structured, responsive team.</li><li>
Professional Growth: Be part of a company that invests in your career through continued learning, mentorship, and leadership opportunities.</li><li>
Stability and Vision: Work with a leading global organization known for operational excellence and long-term partnerships in clinical research.</li></ul>
If you're passionate about clinical research and want to make a direct impact on advancing biomarker science, we&rsquo;d love to hear from you.
Apply now and be part of a team shaping the future of clinical development.
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:
$95,000.00 - $175,700.00
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
Roles within Clinical Project Management job family at the M23 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. Responsibilities include site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. These roles also involve monitoring progress and following up with team members and line managers when issues develop. Additionally, they implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies.Impact and ContributionRoles within Clinical Project Management job family at the M23 level significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By gathering input from cross-functional teams and creating detailed plans, these roles help ensure that deliverables are produced on schedule, contributing to the overall success of the clinical trials. Their oversight of operational aspects of clinical trials ensures consistency and adherence to SOP, GCP, and country regulations, which is crucial for the integrity and reliability of the study results. Additionally, their involvement in site and vendor selection, budget preparation, and monitoring progress helps maintain the smooth operation of clinical trials, ultimately contributing to the advancement of clinical research and development.Core Focus&bull;Planning, directing, creating, and communicating clinical study timelines&bull;Overseeing operational aspects of clinical trials&bull;Ensuring consistency across clinical studies&bull;Adhering to SOP, GCP, and country regulations&bull;Selecting sites and vendors&bull;Preparing clinical trial budgets&bull;Monitoring progress and following up with team members and line managers&bull;Implementing and preparing the clinical development strategy&bull;Developing trial recruitment strategies</div>

Clinical Project Manager II – Biomarker Study Management (Sponsor-Dedicated | Remote)

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Clinical Project Manager II – Biomarker Study Management (Sponsor-Dedicated | Remote)