Senior Clinical Research Manager

1 week ago

Kozhikode, Kerala, India beBeeClinicalResearch Full time ₹ 14,30,000 - ₹ 2,43,10,000
Lead Clinical Research Executive

This role involves managing and overseeing clinical trials from inception to completion.

Responsibilities:
  • Plan, initiate, and manage clinical research projects ensuring timely execution and compliance with regulatory standards.
  • Coordinate the execution of clinical trials adhering to established protocols, timelines, and budgets.
  • Ensure Good Clinical Practice (GCP), regulatory requirements, and ethical standards are met.
  • Oversight on recruitment, enrolment, and monitoring of clinical trial subjects is provided.
Team Leadership & Management:
  • Lead and mentor a team of clinical 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 & Reporting:
  • Oversee 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.
  • Timely reporting of adverse events is ensured and the study meets ethical and regulatory standards.
Study Design, Protocol Development, Data Management & Reporting:
  • Work with scientific and medical teams to develop clinical trial protocols.
  • Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
  • Evaluate feasibility and risk of proposed studies.
  • Data collection, monitoring, and analysis are conducted efficiently and accurately.
  • Clinical trial data is reviewed and analyzed to ensure quality and integrity.
  • Progress reports are prepared and presented to senior leadership and stakeholders.
Budget & Resource Management:
  • Develop and manage project budgets ensuring clinical trials are completed within financial constraints.
  • Resource allocation including personnel, equipment, and materials is overseen.
Communication, Collaboration & Continuous Improvement:
  • Foster communication between internal teams external partners, and key stakeholders.
  • Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution.
  • Ideas for process improvement in clinical trial execution and management are identified and best practices are implemented to optimize research efficiency and compliance.

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.
  • Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

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