Lead Study Operations Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeSenior Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Clinical Trial Manager

Major responsibilities include:

  • Co-lead the clinical trial team with senior-level oversight and support from operations leaders, delivering multiple complex global studies while promoting learning and operational excellence.
  • Act as the product owner for clinical trials with duties and responsibilities for strategic delivery.
  • Guide planning and decision making at the study level, ensuring timely completion of assigned clinical studies per established plans.
  • Develop a collaborative agile culture to achieve sprint goals and cycles, minimizing dependencies for long-term business impact.
  • Work with regulatory and clinical development teams to promote operational excellence by translating approved study concepts into efficient protocols and documents.
  • Create effective dynamics among clinical trial teams, achieving high performance, prioritization, and communication in collaboration with sub-team leaders.
  • Proactively manage risks and ensure inspection readiness.
  • Responsible for developing study timelines and overseeing budgets with oversight from operations leaders.
  • Ensure systems are maintained with up-to-date study status, risks, and issues.
  • Build strong relationships with clinical project managers to strengthen global and local team collaboration.
  • Oversee recruitment efforts and implement mitigation strategies in collaboration with clinical project managers.
  • Establish close working relationships with vendor partnerships and governance teams to deliver on clinical objectives.
  • Collaborate with clinical data operations teams to achieve study objectives.
  • Ensure proper handling of all study close-out activities, including site closure, drug accountability, and audit readiness.
  • Promote operational excellence and contribute to reporting and publication of clinical trial results, when appropriate.

Key qualifications include:

  • 4+ years of recent experience in clinical research or drug development spanning Phases I through IV of standard to high complexity and priority.
  • 3+ years of contribution to and accomplishment in conducting clinical studies of standard to high complexity and priority in a global environment, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), and Novartis standards.
  • Experience managing people globally in a complex matrix environment, with proven ability to lead teams and build capabilities.
  • Excellent communicator and presenter with the ability to communicate at all levels.
  • Strong organization and prioritization skills.
  • Effective negotiation and conflict resolution skills, along with an enterprise mindset.
  • Strong project management skills and demonstrated ability to meet timelines.

Required skills include:

  • Budget Management
  • Clinical Trials
  • Negotiation Skills
  • People Management
  • Process Improvement
  • Project Planning
  • Vendor Management

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