Clinical Trial Operations Lead

4 days ago

Nashik, Maharashtra, India beBeeClinicalResearch Full time ₹ 8,00,000 - ₹ 15,00,000
Job Overview:

The Senior Clinical Research Manager oversees clinical trials, ensuring timely completion and regulatory compliance.

Responsibilities:

  1. Plan, initiate, and manage clinical research projects from start to finish.
  2. Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
  3. Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.

Leadership Qualities:

  • Lead and mentor 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 Expertise:

  1. Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.
  2. Monitor compliance with federal, state, and local regulations, as well as company policies.
  3. Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards.

Study Design & Protocol Development:

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

Data Management and Reporting:

  1. Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
  2. Review and analyze clinical trial data to ensure quality and integrity.
  3. Prepare and present progress reports to senior leadership and stakeholders.

Budget and Resource Management:

  1. Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.
  2. Oversee resource allocation, including personnel, equipment, and materials.

Collaboration and Communication:

  1. Foster communication between internal teams, external partners, and key stakeholders.
  2. Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution.
  3. Resolve any issues related to clinical trial execution and provide solutions.

Qualifications:

  1. Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
  2. 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
  3. In-depth knowledge of clinical trial management, regulatory requirements, and GCP.
  4. Strong project management, leadership, and organizational skills.
  5. Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
  6. Proficiency in clinical research software and data management systems.
  7. Strong problem-solving and decision-making abilities.
  8. Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

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