Clinical Research Operations Manager

10 hours ago

Thiruvananthapuram, Kerala, India beBeeClinicalResearchManager Full time ₹ 40,00,000 - ₹ 80,00,000

Key Responsibilities:

  • Plan, initiate, and manage research projects from inception to completion.
  • Oversee the execution of studies, ensuring adherence to protocols, timelines, and regulatory requirements.
  • Ensure compliance with Good Clinical Practice (GCP), regulatory standards, and ethical guidelines.
  • Provide oversight on the recruitment, enrolment, and monitoring of study subjects.
  • Manage relationships with organizations, investigators, and external vendors.

Team Leadership

  • Lead and mentor research staff, ensuring they are trained and performing effectively.
  • Assign tasks and responsibilities to team members based on project needs.
  • Develop training programs and provide ongoing professional development for research teams.

Regulatory Compliance

  • Oversee the preparation and submission of regulatory documentation, including institutional review board (IRB) applications and study approvals.
  • Monitor compliance with federal, state, and local regulations, as well as company policies.
  • Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards.

Study Design & Protocol Development

  • Work with scientific and medical teams to develop study protocols.
  • Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
  • Evaluate feasibility and risk of proposed studies.

Data Management and Reporting

  • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
  • Review and analyze study data to ensure quality and integrity.
  • Prepare and present progress reports to senior leadership and stakeholders.

Budget and Resource Management

  • Develop and manage project budgets, ensuring that studies are completed within financial constraints.
  • Oversee resource allocation, including personnel, equipment, and materials.

Clinical Research Management

  • Foster collaboration between internal teams, external partners, and key stakeholders.
  • Collaborate with research coordinators, data managers, and other departments to ensure effective study execution.
  • Resolve any issues related to study execution and provide solutions.

Qualifications:

• Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
• 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
• In-depth knowledge of clinical trial management, regulatory requirements, and GCP.
• 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.
• Strong problem-solving and decision-making abilities.
• Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

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