Clinical Team Lead

20 hours ago

Ahmedabad, Gujarat, India 9b7c2777-6f80-4c7b-9229-4f12e4df35de Full time ₹ 12,00,000 - ₹ 36,00,000 per year

BioDev is looking for experienced Clinical Team Leads for its growing portfolio of international clinical trials & pharma R&D projects. Only candidates with experience of at least 2 years in Phase 1/2/3 clinical trials and Site Monitoring will be considered. These will be office based, travelling roles - locations Ahmedabad. An understanding of allied services like Data Management (EDC, ePRO tools), Laboratory management, Statistics will be of great value.

A clinical Team Lead oversees the entire clinical operation lifecycle of a clinical trial, from initial planning and setup to final data analysis and reporting. Key responsibilities include developing project plans, managing budgets and timelines, ensuring regulatory compliance, leading Clinical Operation teams, and serving as the main point of contact between Sponsors, Sites, Other functional teams & ClinOps team. They monitor trial progress, identify and mitigate risks, and ensure all documentation is accurate and compliant.

The role of a CTL is an effective stepping stone - to prepare one's self for a career in Project management/ leadership in pharma R&D.

Key responsibilities

  • Project planning and initiation:
     Define project scope, objectives, and deliverables. Create detailed project plans, budgets, and timelines.
  • Team and vendor management:
     Assemble and lead ClinOps team & coordinates with other functions including data managers, statisticians, and regulatory experts other vendors etc.
  • Regulatory compliance:
     Ensure the trial adheres to all relevant regulations, such as Good Clinical Practice (GCP) guidelines from the FDA and EMA. Maintain and review all necessary documentation.
  • Risk management:
     Proactively identify potential risks to the project and develop mitigation strategies to keep the trial on track.
  • Budget and financial oversight:
     Manage the study budget, track expenses, and ensure cost-effectiveness.
  • Data and quality management:
     Ensure the accuracy and completeness of trial data and collaborate with data management teams.
  • Communication and leadership:
     Act as the primary liaison between the sponsor, clinical sites, Other functional teams. Lead meetings and provide regular, clear updates to stakeholders.

Skills and qualifications

  • Project management:
     Proficiency in project planning, scheduling, budgeting, and risk management.
  • Clinical research knowledge:
     Understanding of clinical trial protocols, processes, and regulatory compliance.
  • Leadership and communication:
     Strong leadership, team management, and communication skills.
  • Problem-solving:
     Ability to identify issues and develop effective solutions.
  • Attention to detail:
     Meticulousness in reviewing documents and data.
  • Education:
     Typically a bachelor's degree in a life science field, with experience in clinical trials monitoring of at least 2 years

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