Senior Study Leader

Job Description

Major accountabilities:

- 1.Co-leads the clinical trial team with the CSL with per needed-basis oversight from the Study Director-community Lead (SD-CL) and support from the Clinical Operations Program Head (COPH), delivery of multiple medium to complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and a team of teams model
- 2. Acts as the CTT product owner with duties and responsibilities for delivery of operational strategy per established ways of working
- 3. Guides planning and decision making at the study level and delivers assigned clinical study/studies per the Operational Execution Plan (OEP) and clinical study protocol
- 4. Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies to achieve long-term business impact
- 5. In collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
- 6. Create effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leaders
- 7. Proactive risk management and inspection readiness
- 8. Responsible for developing clinical study timelines with per needed-basis oversight from the Study Director-community Lead (SD-CL) and support from the Clinical Operations Program Head (COPH), and overseeing assigned study budgets
- 9. Ensures systems are maintained with up-to-date study status, risks, and issues
- 10. Fosters a close working relationship with SSO Clinical Project Managers (CPMs) to strengthen the relationship between the global and local teams
- 11. Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Project Managers (CPMs)
- 12. Fosters a close working relationship with the Vendor Partnerships & Governance (VPG) Trial Vendor Managers (TVMs) to strengthen the relationship between the vendors and CTT to deliver on clinical study objectives
- 13. Fosters a close working relationship with the Clinical Data Operations (CDO) Trial Data Scientist (TDS) to deliver on clinical study objectives
- 14. Ensures proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation
- 15. Promotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriate
- 16. May deputize for the Clinical Operations Program Head as a leader and spokesperson for the CTT at Novartis internal meetings
- 17. Partners and collaborates with Portfolio Strategy & Planning (PSP)/COPH to deliver clinical studies in alignment with program strategy
- 18. Play a key role in achieving excellence in study operations and management through process improvement in collaboration with the Study Leadership Community Lead/Host and GCO Process, Training, and Compliance (PTC)

Work Experience:

- 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard to high complexity and priority
- 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
- Experience in managing people globally in a complex matrix environment preferred Management of virtual teams. Proven ability and strong experience leading teams and building capabilities Experience in developing effective working relationships with internal and external stakeholders Excellent communicator and presenter (oral and written); ability to communicate at all levels
- Excellent organization and prioritization
- Strong negotiation and conflict resolution skills and enterprise mindset
- Strong project management skills and demonstrated ability to meet timelines

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model

---