Senior Study Operations Leader

2 days ago

Hyderabad Secunderabad Telangana, India beBeeStudyLeader Full time

As a senior leader in clinical trials, you will play a pivotal role in driving operational excellence and promoting learning within the team. Key responsibilities include co-leading the clinical trial team with oversight from the study director and community lead, as well as ensuring timely delivery of multiple global studies.

To be successful in this role, you will need to possess excellent communication skills, both written and verbal, as well as the ability to collaborate effectively with cross-functional teams. Additionally, experience in managing virtual teams and building capabilities is highly desirable.

A strong understanding of international standards (GCP/ICH) and local health authorities regulations is also essential. You will be responsible for overseeing assigned study budgets and ensuring systems are maintained with up-to-date study status, risks, and issues.

The ideal candidate will have at least 4 years of recent involvement in clinical research or drug development, with experience spanning clinical activities in Phases I through IV of standard to high complexity and priority.

  • Key Accountabilities:
  • 1. Co-leads the clinical trial team with per needed-basis oversight from the Study Director-community Lead
  • 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
  • 4. Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies
  • 5. 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. Creates effective CTT dynamics and achieves 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 and support from the Clinical Operations Program Head
  • 9. Ensures systems are maintained with up-to-date study status, risks, and issues

Required Skills and Qualifications:

  • Excellent communication and interpersonal skills
  • Strong organizational and prioritization skills
  • Ability to work effectively in a complex matrix environment
  • Experience in managing people globally preferred
  • Expert knowledge of international standards (GCP/ICH)
  • Health authorities (FDA/EMA) regulations
  • Local/National Health Authorities regulations
  • Novartis standards

Benefits:

This role offers a unique opportunity to drive operational excellence and promote learning within the team. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply.

Others:

We are an equal opportunities employer and welcome applications from all qualified candidates.

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