Senior Global Clinical Operations Manager

1 day ago

Hyderabad, Telangana, India beBeeClinical Full time ₹ 22,50,000 - ₹ 2,62,50,000
Job Title: Senior Clinical Operations Lead

As a Senior Clinical Operations Lead, you will co-lead the clinical trial team with the study director, overseeing multiple global studies. You will promote learning, sharing, consistent performance, and operational excellence through an agile mindset and team of teams model.

Key Responsibilities:
  • Co-lead the clinical trial team with the study director.
  • Act as the CTT product owner, delivering operational strategy per established ways of working.
  • Guide planning and decision making at the study level, delivering assigned clinical studies per the Operational Execution Plan (OEP) and clinical study protocol.
  • Foster an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies to achieve long-term business impact.
  • Promote operational excellence in the development of global clinical study protocols, by translating approved study concept sheets into efficient, high-quality, executable clinical protocols, and study-related documents.
  • Create effective CTT dynamics and achieve on-performance, prioritization, and communication in close collaboration with CTT sub-team leaders.
  • Proactive risk management and inspection readiness.
  • Responsible for developing clinical study timelines with needed oversight from the Study Director-community Lead (SD-CL) and support from the Clinical Operations Program Head (COPH), and overseeing assigned study budgets.
  • Ensure systems are maintained with up-to-date study status, risks, and issues.
  • Foster a close working relationship with SSO Clinical Project Managers (CPMs) to strengthen the relationship between the global and local teams.
  • Oversee study recruitment and be responsible for activating mitigation strategies in collaboration with the SSO Clinical Project Managers (CPMs).
  • Foster 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.
  • Foster a close working relationship with the Clinical Data Operations (CDO) Trial Data Scientist (TDS) to deliver on clinical study objectives.
  • Ensure 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.
  • Promote operational excellence and contribute to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriate.
  • May deputize for the Clinical Operations Program Head as a leader and spokesperson for the CTT at Novartis internal meetings.
  • Partners and collaborates with Portfolio Strategy & Planning (PSP)/COPH to deliver clinical studies in alignment with program strategy.
  • 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).

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