manager clinical

ICON plc

<div>Manager Clinical Data Science, Trivandrum, India<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Manager, Clinical Data Science to join our diverse and dynamic team. As a Manager, Clinical Data Science at ICON, you will play a pivotal role in overseeing the analysis and interpretation of clinical data to support drug development and improve patient outcomes. You will contribute to the advancement of innovative treatments through strategic leadership in data management and analytics, ensuring the highest standards of quality and compliance in clinical research.</div><div>
What You Will Be Doing:</div><div></div><ul><li>
Driving the analysis of clinical trial data to derive actionable insights and support decision-making processes.</li><li>
Collaborating with cross-functional teams to ensure effective data collection, management, and reporting throughout clinical trials.</li><li>
Overseeing the implementation of best practices in data science methodologies and technologies within the organization.</li><li>
Providing mentorship and guidance to junior data scientists, fostering a culture of continuous improvement.</li><li>
Establishing strong partnerships with internal and external stakeholders to enhance data integrity and optimize clinical outcomes.</li></ul><div>
Your Profile:</div><div></div><ul><li>
Advanced degree in a relevant field such as biostatistics, data science, or a related discipline.</li><li>
Extensive experience in clinical data analysis, with a solid understanding of regulatory requirements and industry standards.</li><li>
Strong leadership skills with the ability to inspire and manage teams effectively in a collaborative environment.</li><li>
Proficiency in statistical software and programming languages, with a keen ability to translate complex data into clear insights.</li><li>
Excellent communication and interpersonal skills, with a track record of influencing stakeholders and driving positive change.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Manager Clinical Data Science

Bristol Myers Squibb

<div>
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  Working with Us
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 Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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 Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:  careers.bms.com/working-with-us .
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 Manager, Clinical Trial Risk Analyst
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 Trial Delivery Support (TDS)/Trial Risk &amp; Integrity Management (TRIM)
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  Position Summary
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 The Manager, Clinical Trial Risk Analyst (Mgr CTRA), is a member of the Clinical Trial Risk Management team under Trial Risk &amp; Integrity Management (TRIM).
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 The Clinical Trial Risk Management capability is a critical element of the Risk Based Management (RBM) framework.
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 Each Mgr CTRA will be assigned a certain part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function in conducting risk oversight to identify potential risks and control strategies. This role is responsible for the remote assessment of risk and data quality analytics that monitor issues and identify emerging risks in study-specific variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical methodologies.
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 The Mgr CTRA will be responsible for study-level risk analysis and reporting and will be key contributor to the clinical study team to support the oversight of the sites/countries/studies for compliance, patient safety, data quality and reliability.
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 The Mgr CTRA role has accountability to evaluate, monitor, escalate and report risks to the Clinical Trial Risk Lead (CTRL) that could potentially have a broad significant and/or systemic impact on quality, compliance, and operational deliverables for discussion with the relevant Governance Committee.
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 The Mgr CTRA forms a key partnership with the CTRL, R&amp;D Quality (Risk Governance and Operations), applicable GDO &amp; TA functions.
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  Duties/Responsibilities
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   Mgr CTRA to contribute to Protocol De-risking process, support identification of critical to success factors, critical to quality factors - including critical data, critical processes
  </li>
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   Collaborate with the Data Management Lead (DML), Statistician, Global Trial Lead (GTL), Quality Lead, Clinical Trial Physician, Clinical Scientist and other study team members to put together an initial proposal on KRIs (standard and study specific) and Quality Tolerance Limits (QTLs). Proposal to include information on critical data, data source, data flow, data review frequency, external data transfer frequency etc.
  </li>
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   Responsible to lead and collaborate with the study team in the development of specifications to set up the KRIs, Data Quality Assessments (DQA) and QTLs.
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   Partners with the DML and other data review functions to determine the holistic data review strategy for the study and determines the function-specific review objectives/analytics. Documents the Risk Monitoring data analysis responsibilities in the relevant functional plan.
  </li>
  <li>
   Responsible for regular risk monitoring at study level for and providing a holistic risk report at the agreed frequency. Ensure appropriate escalations of emerging risks (including QTL deviations) to the CTRL to be discussed at relevant governance bodies (e.g. Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the TRIM group.
  </li>
  <li>
   Triages new and previously open signals in preparation for the Risk Review Meetings (RRM) to prioritize the signals for discussion and prepare a list of recommended actions
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   Contribute to the Risk Review discussion to determine if newly opened signals reveal potential risks and require follow-up investigation and if previously opened signals can be closed or need further investigation/monitoring/action. Relates the insights from the CM analysis back to the original risk discussions to share a compelling 'risk story'.
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   Drives or contributes to ongoing risk discussions within the study team throughout the lifecycle of the trial and ensures the risk management plan is updated and remains current
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   Contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness.
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   Participation in initiatives / continuous improvement opportunities within the TRIM and broader organizations
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   Supports the strategic direction of Risk Based Management within the business to include leadership of RBM innovation, education and embedding
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   Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing Risk Management or Risk Monitoring activities on behalf of BMS
  </li>
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   Takes on additional responsibilities as directed by leadership
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  </li>
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  Reporting Relationship
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 This role will report to a Clinical Trial Risk Analyst Line Manager within the TRIM organization.
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  Qualifications
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 A minimum of a bachelor's degree in one of the following disciplines or related field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is required.
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 At least 3 years in the pharmaceutical industry with sound understanding of drug development and 3 years of experience in clinical trial operations and/or Good Clinical Practice is required.
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 Robust understanding of Risk-Based Monitoring principles (Quality by Design, Risk Assessment &amp; Control) and relevant tools (e.g. RACT, risk analytics platforms, Veeva and other quality systems)
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 Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights; and an ability to effectively tell the story of the data findings
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 Ability to contribute to the development and implementation of data visualizations and analyses to support Risk Management / Risk Monitoring business needs.
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 Robust understanding of GCP, compliance and regulatory expectations. Experience of audits and health authority inspections, root cause analysis and CAPA is desirable.
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 Strong leadership skills with an ability to influence and manage key internal stakeholders
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 Excellent communication, collaboration and teamwork skills with an ability to drive cross-functional stakeholders to consensus.
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 An ability to create a compelling story based on data insights which is meaningful to the target audience.
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 An ability to make the connection between organizational strategy and departmental objectives, and utilize this understanding to drive priorities
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 Open mindset with an ability to be flexible, responsive, and proactive in addressing new challenges, opportunities, and demands.
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 Ability to quickly adapt to changes while maintaining effectiveness and staying aligned with business goals
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 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
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 <strong>
  Uniquely Interesting Work, Life-changing Careers
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 With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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  On-site Protocol
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  Responsibilities
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 BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
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 <br/>
 Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to  adastaffingsupport@bms.com  . Visit  careers.bms.com/  eeo  -accessibility  to access our complete Equal Employment Opportunity statement.
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 BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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 <br/>
 BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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 <br/>
 If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:  https://careers.bms.com/california-residents/
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 Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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Manager, Clinical Trial Risk Analyst

Greys Specialist Recruitment

<p>Exciting Opportunity: Occupational Health Manager Clinical Lead</p><p>Are you a passionate and experienced Registered Nurse looking to take the next step in your occupational health career?</p><p>We have an excellent opportunity for a dedicated Occupational Health Manager to join a successful organisation in beautiful Barrow in Furness!</p><p><strong>Position:</strong> Occupational Health Manager Clinical Lead</p><p><strong>Location:</strong> Barrow in Furness <strong>Type:</strong> Full-Time, Permanent</p><p><strong>Hours:</strong> Monday to Friday, 8am - 4pm (On-site)</p><p><strong>What You'll Be Doing:</strong></p><p>You will play a pivotal role in guiding and supporting our clinical team, ensuring the delivery of high-quality occupational health services. Your responsibilities will include conducting clinical competency reviews, leading wellbeing initiatives, and helping to coordinate programs that promote employee health and safety.</p><p><strong>What We're Looking For:</strong></p><ul><li>A registered nurse with a valid NMC pin</li><li>Proven experience working as an Occupational Health Advisor</li><li>Strong leadership skills with the ability to support and motivate a clinical team</li><li>A proactive approach to wellbeing and health promotion</li></ul><p><strong>Apply today and take the next step in your occupational health career!</strong></p>

Occupational Health Manager Clinical Lead

Regeneron

<div><p>We are seeking a Senior Manager to join our Clinical Sciences team within Regeneron Genetics Medicine. Qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. You will work closely with supervisor and other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC).<br>
</p><p></p><p>As a Senior Manager, a typical day may include the following:<br>
</p><p><br>
- Supports the cross-functional study team on the following activities, including but not limited to:
</p><p>- Contributes to the writing of sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
</p><p>- Assists with identifying key internal and external collaborators/advisors, organizes consultations with global subject matter experts
</p><p>- Represents the clinical ECD&amp;ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
</p><p>- Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
</p><p>- Drafts portions of the clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator&rsquo;s brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
</p><p>- Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
</p><p>- Trains and support study team and CRO personnel regarding clinical aspects of trial
</p><p>- Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
</p><p>- Organizes steering committees, advisory boards, and data safety monitoring boards as required
</p><p>- Identifies program, trial or data risks, creates and implements mitigation strategies
</p><p>- Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
</p><p>- Provides background literature searches in support of:
</p><p>- Early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints
</p><p>- POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy<br>
</p><p></p><p>This role may be for you if:<br>
</p><p><br>
- Effective communications (verbal &amp; written) and presentation skills are essential
</p><p>- Must be able to work productively in a fast-paced collaborative environment
</p><p>- Demonstrated/potential for critical thinking skills and sound decision-making<br>
</p><p></p><p>To be considered for this role, you must have a Bachelor&rsquo;s degree. Ph.D., PharmD. or Master&rsquo;s degree in biomedical subject. Additionally, we are seeking 8 years of clinical research/development experience
</p><p></p><div><div><div><div><div><div><div><p>Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries&rsquo; specific benefits, please speak to your recruiter.
<br>
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron&rsquo;s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron&rsquo;s on-site policy and expectations for your role and your location.<br>
<br>
</p><p></p><p>Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
</p><p></p><p>For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
</p><p></p><p>Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
</p><p></p><p><b>Salary Range (annually)
</b></p></div></div></div></div></div></div></div>$150,500.00 - $245,500.00</div>

Senior Manager, Clinical Scientist, Genetics Medicine

Novartis

<div><div><h3 class="jobSectionHeader"><b>Summary
</b></h3><div>The Global Category Manager for Biomarkers and Imaging leads strategic procurement activities for these and other clinical categories at a global level. This role delivers high-value sourcing solutions, supports vendor selection and development, manages supplier performance, and ensures best-in-class external services for clinical studies. The position drives productivity improvements, cost savings, and process enhancements in close collaboration with business stakeholders.</div>
</div><div><h3 class="jobSectionHeader"><b>About the Role
</b></h3><div><p><b>Major accountabilities:
</b></p><ul><li>Develop and implement global category strategies for Biomarkers and Imaging to support Novartis&rsquo; clinical development pipeline.</li><li>
Lead sourcing, negotiation, and contracting activities to optimise value and leverage buying power across assigned categories.</li><li>
Establish and maintain governance frameworks for preferred suppliers to ensure performance, innovation, and continuous improvement.</li><li>
Negotiate complex commercial agreements, including Master Services Agreements, in collaboration with Legal, Data Privacy, and Quality teams.</li><li>
Deliver category savings and process improvements, managing supplier performance and driving innovation initiatives.</li><li>
Provide financial and market analysis, including supplier spend insights and global intelligence, acting as subject matter expert for stakeholders.</li><li>
Support development of Clinical Sourcing Managers, assisting with goal setting and performance reviews within the category.</li><li>
Ensure compliance with Novartis procurement policies and contribute to global procurement objectives.</li></ul><p><b>
Minimum Requirements:
</b><br>
<b>Work Experience:
</b></p><ul><li>Minimum 7 years in strategic negotiations and operations within R&amp;D at a pharmaceutical company or CRO</li><li>
Strong understanding of clinical processes, study management, and integration of clinical data systems</li><li>
Proven project management and leadership experience</li><li>
Knowledge of global R&amp;D clinical CRO market</li></ul><p><b>
Education</b></p><ul><li>
Master&rsquo;s degree in Life Sciences or Pharmaceutical Sciences</li><li>
MBA preferred</li></ul><p></p><p><b>
Why Novartis?</b></p><p>
At Novartis, we are reimagining medicine to improve and extend people&rsquo;s lives. We are committed to building an inclusive environment where diverse perspectives drive innovation and excellence. Join us to make a meaningful impact on global health and be part of a team that values curiosity, collaboration, and courage.</p><p></p><p><b>
Commitment to Diversity &amp; Inclusion</b></p><p>
Novartis is an equal opportunity employer and does not discriminate based on race, colour, gender, age, religion, sexual orientation, disability, or any other protected characteristic. We strive to create an inclusive workplace that reflects the communities we serve.</p><p></p><p><b>
Languages :</b></p><ul><li>
English.</li></ul></div>
</div><div><div><p><b>Why Novartis:</b> Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture</p><p><b>
Join our Novartis Network:</b> Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network</p><p><b>
Benefits and Rewards:</b> Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards</p></div></div></div>
<br><div><div>Division
<div>Operations
</div></div><div>Business Unit
<div>Universal Hierarchy Node
</div></div><div>Location
<div>India
</div></div><div>Site
<div>Hyderabad (Office)
</div></div><div>Company / Legal Entity
<div>IN10 (FCRS = IN010) Novartis Healthcare Private Limited
</div></div><div>Alternative Location 1
<div>Selangor, Malaysia
</div></div><div>Functional Area
<div>Procurement
</div></div><div>Job Type
<div>Full time
</div></div><div>Employment Type
<div>Regular
</div></div><div>Shift Work
<div>No
</div></div><div>
</div><div><h3 class="jobSectionHeader"><b>Accessibility and accommodation</b></h3><p>
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.</p>
</div><div><p>Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.</p></div></div><div></div>

Global Category Manager Clinical R&D

Cedars-Sinai Medical Center

<p></p><div><div><div><div><p><b>Job ID</b> 13386</p>
<p><b>Location</b> United States
</p><p><b>Job Category</b> Clinical Operations
</p><p><b>Date posted</b> 11/10/2025</p>
</div></div><p></p><div>
<div><b>Save Job</b></div>
<div><b>Employees: Apply Here</b></div>
</div></div><div><h2 class="jobSectionHeader"><b>Job Description</b></h2><div><p>
The Manager, MN Clinical Operations supports the safe and effective delivery of patient care services in the Cedars-Sinai Medical Care Foundation. Is responsible for daily operations of the clinical operations team, clinical education, supervision and development of staff, performance improvement, and enhancement of the profitability of assigned areas. Participates in Foundation support initiatives. Ensures compliance with all regulatory agency requirements.</p>
Duties and Responsibilities:
Manages staff, assigns and delegates responsibilities within the scope of practice to the appropriately licensed and unlicensed health care providers as indicated. Oversees daily operations and leads department using <ul><li>d governance model and Lean principles of management.</li><li>
Uses expert knowledge, clinical skills and critical thinking in managing daily delivery of support services ensuring implementation of the appropriate clinical processes and coordinating/improving an interdisciplinary team approach.</li><li>
Ensures efficient levels of clinical efficiency and services for all customers.</li><li>
Participates in the interviewing, hiring, evaluation and human resource management functions of the staff.</li><li>
In collaboration with the Director of Clinical Operations, develops goals and operations/business plans for clinical operations specifically, and as a component of the continuum of care within CSMCF.</li><li>
Establishes and maintains patient care standards and ensures that patient care functions are completed safely and effectively.</li><li>
Ensures that Nursing Standards of Practice and best standard methodologies are implemented.</li><li>
Plans, implements, evaluates and documents the orientation and appraisal processes for the clinical operations staff.</li><li>
Conducts formal and informal evaluations of staff proficiency, determining staff educational needs, and providing structured assistance in areas needing improvement.</li><li>
Provides staff training, as needed, both informally and in formal in-service presentations.</li><li>
Acts as an expert of the electronic medical record, training new staff, implementing new functionality and providing ongoing direction for system utilization.</li><li>
Assists the Senior Clinical Operations Manager in developing and managing the budget for responsible services.</li><li>
Ensures compliance with drug safety and administration guidelines.</li><li>
Provides direct patient care as needed.</li><li>
Forecasts and plans for appropriate resource utilization</li></ul></div><h2 class="jobSectionHeader"><b><br>
Qualifications</b></h2><div><h2 class="jobSectionHeader"><b>
Education:</b></h2><p>
High school diploma/GED required. Bachelor's degree in Nursing, Business or Healthcare Administration preferred.</p><h2 class="jobSectionHeader"><b>
License /Certification:</b></h2><p>
Valid Basic Life Support (BLS) from American Heart Association or American Red Cross preferred. Ambulatory Care Nursing (AAACN certification) preferred.</p><h2 class="jobSectionHeader"><b>
Experience:</b></h2><p>
Five (5) years supervisory experience, three (3) of which is in an inpatient or outpatient clinical setting required.</p></div><h2 class="jobSectionHeader"><b><br>
About Us</b></h2><p>
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.</p><h2 class="jobSectionHeader"><b><br>
About the Team</b></h2><p>
With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai&rsquo;s medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.</p><br>
<b>
Req ID</b> : 13386<br>
<b>Working Title</b> : Manager, MN Clinical Operations - Operations<br>
<b>Department</b> : Operations<br>
<b>Business Entity</b> : Cedars-Sinai Medical Care Foundation<br>
<b>Job Category</b> : Clinical Operations<br>
<b>Job Specialty</b> : Clinical Operations<br>
<b>Overtime Status</b> : EXEMPT<br>
<b>Primary Shift</b> : Day<br>
<b>Shift Duration</b> : 8 hour<br>
<b>Base Pay</b> : $57.33 - $94.60</div>
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Manager, MN Clinical Operations - Operations

Syneos Health

<div><p><b>Description</b>
</p>Clinical Project Manager II &ndash; Biomarker Study Management (Sponsor-Dedicated | Remote)<p></p><p>
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.</p><p>
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.</p><p></p><p>
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.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><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><p></p><p><b>
Job Responsibilities</b></p><p></p><h2 class="jobSectionHeader"><b>
Clinical Project Manager II &ndash; Biomarker Study Management</b><br>
<b>(Sponsor-Dedicated | Remote)</b></h2><p>
We&rsquo;re hiring a <b>Clinical Project Manager II</b> with a strong background in <b>biomarker study operations</b> 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.</p><p>
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.</p><p><b>
What You&rsquo;ll Do:</b></p><p><b>
Lead Biomarker Study Operations</b></p><ul><li><p>
Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs</p></li><li><p>
Serve as the operational point of contact for all biomarker-related processes</p></li><li><p>
Work closely with clinical study teams (Phases 1&ndash;4) to integrate biomarker strategies into broader clinical development plans</p></li><li><p>
Plan and manage the collection, tracking, and analysis of biological specimens</p></li><li><p>
Advise study teams on best practices for sample management and logistics</p></li></ul><p></p><p><b>
Drive Clinical Project Delivery</b></p><ul><li><p>
Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout</p></li><li><p>
Ensure studies stay on track with respect to timelines, budget, scope, and quality</p></li><li><p>
Act as the main liaison between the sponsor and study partners</p></li><li><p>
Monitor and manage project financials, ensuring fiscal responsibility</p></li><li><p>
Proactively identify and resolve operational issues and risks</p></li></ul><p></p><p><b>
Ensure Operational Excellence</b></p><ul><li><p>
Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness</p></li><li><p>
Keep study systems and databases current and audit-ready</p></li><li><p>
Prepare project reports and updates for sponsors and internal stakeholders</p></li><li><p>
Plan and facilitate internal and external meetings</p></li><li><p>
Support inspection readiness and regulatory compliance throughout the project</p></li></ul><p></p><h2 class="jobSectionHeader"><b>
Skills and Experience You Bring:</b></h2><ul><li><p>
Significant experience managing biomarker studies and external vendors required!</p></li><li><p>
Strong understanding of biomarker and bioanalytical strategies in a clinical trial setting</p></li><li><p>
Proven ability to coordinate complex sample collection and analysis workflows</p></li><li><p>
Expertise in supporting study teams with sample logistics and operational planning</p></li><li><p>
Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience</p></li><li><p>
Experience in a clinical research organization (CRO) or sponsor environment preferred</p></li><li><p>
Familiarity with GCP, ICH guidelines, and global regulatory standards</p></li><li><p>
Strong project management, organizational, and communication skills</p></li><li><p>
Comfortable working independently and embracing new technologies</p></li><li><p>
Willingness to travel up to 25% as needed</p></li></ul><h2 class="jobSectionHeader"><b>
Why Join Us:</b></h2><ul><li><p><b>
Meaningful Work:</b> Your contributions will directly support critical biomarker research that shapes the future of clinical development and precision medicine.</p></li><li><p><b>
Global Impact:</b> You'll be working on high-profile studies that span multiple regions, making a real difference in patients&rsquo; lives around the world.</p></li><li><p><b>
Dedicated Team:</b> Join a collaborative, sponsor-dedicated environment where your expertise is trusted, and your voice matters.</p></li><li><p><b>
Flexibility:</b> Enjoy the freedom of a fully remote role with the support of a structured, responsive team.</p></li><li><p><b>
Professional Growth:</b> Be part of a company that invests in your career through continued learning, mentorship, and leadership opportunities.</p></li><li><p><b>
Stability and Vision:</b> Work with a leading global organization known for operational excellence and long-term partnerships in clinical research.</p></li></ul><p></p><p>
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.</p><p></p><p><b>
Apply now and be part of a team shaping the future of clinical development.</b></p><p></p><p>
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.</p><p></p><p>
Salary Range:</p>
$95,000.00 - $175,700.00<p></p><p>
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.</p><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
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.</p><p></p><p>
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.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
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.</p><p><b>
Summary</b>
</p>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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