R&D - CSO - Clinical Operations Study Lead - BJ

Clinical Operations Study Lead (COSL) is the operational lead in clinical studies, accountable for the proper execution and delivery of his/her trial for all aspects of the clinical study (end-to-end). He/she is accountable for implementing the operational plan (OP) developed by the COPL for the clinical trial he/she has been assigned. COSL leads a cross-function team to execute the clinical study as outlined in the OP and ensures all trial deliverables are met according to study timelines, within budget, and having the highest quality standards GCP (Good Clinical Practice) /ICH (International Conference on Harmonization), Standard Operating Procedures (SOPs) and/or Quality Documents (QDs). COSL leads the execution of the study with integrity and suitable for regulatory review.

Key interfaces for COSL are the members of Core Study Team, which consists of representatives from CSUs through their Clinical Operations Study Country Lead (COSCL), Data Management, Vendor Management, PVPS (Pharmacovigilance and Patient Safety), Clinical Research Directors/Clinical Scientists, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments.

As the clinical landscape evolves rapidly, COSL leads the Core Study Team with the highest standards for operational excellence while anticipating industry innovations. She/He is an inspiring leader and change agent who brings new innovations and ways of working to clinical operations leveraging digitalization and AI in addition to process improvements (lean).

1. Leads the Study Team on the Planning and Execution of Clinical Studies: Drive and oversee study timelines, monitor budget spending status, quality risks, and escalate risks as needed. Collect, synthesize and report qualitative study information (e.g. risk identification), relying on digital tools for standard information (e.g. enrollment curves, timelines).

• Leads the execution of the study with integrity and suitable for regulatory review. 

• Organize and lead study specific meetings.

• Oversee study progress with Study Team using data driven principles and ensure the training of all members of the study team.

• Actively participates as needed in the Global Project Team meeting to share insights and influence as appropriate.

• Organize global investigator meetings and global communications (teleconferences, news blasts, social media etc.) to the investigators.

• Participate in selection of vendors, oversight of the vendors and support delivery of the service providers, if needed.

• Contribute to data cleaning, RBM and data driven monitoring strategy.

• Accountable for any delegated activity

2. Accountable for the study budget: Prepare the overall Study Budget. Leverage support from our Global Capability Centers (Hubs) to monitor budget spending (and initial assumptions taken) during the study to make forecasts, follow expenses/ accruals, identify and evaluate complementary needs. Work with appropriate support teams to ensure final budget reconciliation at study end.  Alert and escalate to the COPL when a deviation to the budget or budget assumptions occurs. 

3. Ensure proper study documentation/availability

• Develop / co-develop with study team members study documents as per SOP: Study Risk Management Plan (SRMP), Monitoring Plan (MP), Study Communication Plan, Training Material, recruitment and retention plan, and study operational materials including memos, study newsletters, specifications of central services, scope of work, operational manual…

• Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF (Case Report Form) and completion guidelines, Centralized Monitoring Plan, committee charters and/or other operational documents as requested to provide operational input.

• Ensure study documentation is properly maintained and archived in the Trial Master File (TMF)

4. Preparation and oversight of study audits/inspections: Ensure preparation and proper responses to audit/inspection reports for finding associated to study management. Develop and implement immediate action plans with study team, if needed. Prepare and assist in PAI preparation plan with the PAI project team. Utilize designated tools developed to oversee quality (e.g. CTMS reports, PAI Tools kit) for an Inspection-readiness approach.

About You:

1. Master’s degree (preferred) or bachelor’s degree in scientific discipline or equivalent is required; Project Management Professional certification (optional). Experience of collaborating with several internal teams.

2. Significant experience in clinical operations and managing clinical studies with strong project management and project leadership skills.

3. Solid knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs.

4.  Strong ability to act as a project leader of a cross-function Clinical Study Team without direct reporting lines, thus being able to efficiently lead and collaborate in a matrixed environment.

5. Strong in decision making, thoughtful risk-taking and problem-solving skills. Strong critical thinking skills; able to identify and anticipate study risks.

6. Agile and able to deal with frequent changes, delays or unexpected events in clinical studies. Strong ability to lead transformation.

7. Excellent written and verbal communication skills. Strong influencing skills to effectively build relationships with internal and external stakeholders.

8. English language skill: ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents, and present well in internal & external forums.

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