Clinical Trial TL

7 days ago

Pune, Maharashtra, India Suma Soft Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Key Responsibilities:

  • Lead and manage cross-functional clinical trial teams from study start-up to close-out.
  • Develop, implement, and track study timelines, budgets, and operational plans.
  • Ensure trials are conducted in compliance with ICH-GCP, regulatory requirements, and internal SOPs.
  • Oversee the quality and integrity of trial data and ensure timely data entry and cleaning.
  • Serve as the primary point of contact for internal and external stakeholders.
  • Collaborate with vendors, CROs, and investigative sites to ensure smooth trial execution.
  • Identify risks and develop mitigation plans to ensure study milestones are met.
  • Review and approve study documents including protocols, CRFs, ICFs, and monitoring plans.
  • Provide leadership, mentoring, and performance management to the study team.

Required Skills & Qualifications:

  • Bachelors/Masters degree in Life Sciences, Pharmacy, Nursing, or a related field.

  • Strong working knowledge of:

  • Medidata Rave (EDC)

  • Clinical Trial Management Systems (CTMS)

  • Electronic Data Capture (EDC) platforms

  • Excellent understanding of ICH-GCP guidelines and regulatory frameworks.

  • Strong leadership, organizational, and problem-solving skills.

  • Excellent communication and stakeholder management abilities.

  • Experience working with cross-functional teams in a matrix environment.

Interested candidates can apply directly or share your CV at or

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