Senior Clinical Research Leader

1 day ago

Kottayam, Kerala, India beBeeClinicalResearchManager Full time ₹ 22,00,000 - ₹ 29,00,000
Senior Clinical Research Leader

We are seeking an experienced Senior Clinical Research Manager to lead our clinical trials and research studies. This role requires a strong background in clinical research, regulatory compliance, and team leadership.

The successful candidate will have a proven track record of managing clinical research projects from start to finish, ensuring they are completed on time, within budget, and in compliance with regulatory standards.

This is a senior-level position that requires a high degree of autonomy, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced environment.

Key Responsibilities:

  • Clinical Trial Management:
    • Develop and execute clinical research strategies to meet business objectives.
    • Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
    • Maintain regulatory compliance and ensure that all clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines.
  • Team Leadership:
    • Lead and mentor a team of clinical research professionals, providing guidance and support to ensure their success.
    • Develop and implement training programs to enhance the skills and knowledge of team members.
  • Regulatory Compliance:
    • Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.
    • Monitor compliance with federal, state, and local regulations, as well as company policies.
  • Study Design & Protocol Development:
    • Work with cross-functional teams to develop clinical trial protocols.
    • Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
  • Data Management and Reporting:
    • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
    • Review and analyze clinical trial data to ensure quality and integrity.
  • Budget and Resource Management:
    • Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.
    • Oversee resource allocation, including personnel, equipment, and materials.
  • Collaboration and Communication:
    • Foster collaboration between internal teams, external partners, and key stakeholders.
    • Communicate effectively with clinical research coordinators, data managers, and other departments to ensure effective study execution.

Requirements:

  • Education:
    • Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
  • Experience:
    • 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
  • Skills:
    • Strong project management, leadership, and organizational skills.
    • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
    • Proficiency in clinical research software and data management systems.
  • Certifications:
    • Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

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