Team Lead – Clinical Trial Operations – Pune, India (5–8 Years Experience)
Location: Pune, India
Position Type: Full-Time
Experience Required: 5–8 Years
Openings: 1
Job Summary:
We are seeking an experienced Team Lead – Clinical Trial Operations to oversee and manage the planning, execution, and delivery of clinical trials in accordance with ICH-GCP, regulatory requirements, and organizational SOPs. This leadership role will require strategic coordination across cross-functional teams, providing guidance to clinical staff, and ensuring operational excellence across assigned studies.
Key Responsibilities:
Lead and manage a team of Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and site coordinators to ensure timely and high-quality trial execution.
Develop and manage clinical trial plans, timelines, budgets, and resource allocation.
Oversee the day-to-day conduct of clinical trials, ensuring compliance with protocols, SOPs, and regulatory requirements.
Serve as the primary point of contact for clients, investigators, and internal stakeholders for operational trial matters.
Conduct performance evaluations and support the training and mentoring of team members.
Monitor trial progress, proactively identify risks, and implement mitigation strategies.
Ensure audit readiness and support inspection activities.
Review clinical trial documents including protocols, monitoring plans, and status reports.
Requirements:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
5–8 years of relevant experience in clinical trial operations, including 2+ years in a team lead or supervisory capacity.
Strong understanding of ICH-GCP, clinical development processes, and regulatory guidelines.
Proven ability to manage multiple studies and teams effectively.
Excellent leadership, interpersonal, and communication skills.
Proficient in Microsoft Office tools and clinical trial management systems (CTMS).
Estimated Salary: ₹9 – ₹12 LPA (based on experience and skillset)
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