Senior Clinical Research Professional

2 weeks ago

Varanasi, Uttar Pradesh, India beBeeResearch Full time ₹ 80,00,000 - ₹ 1,25,00,000

Job Opportunity:

The position of Senior Manager of Clinical Research is now available.

Overview:

As a key member of our team, you will oversee clinical trials and research studies to ensure timely completion within budget and regulatory compliance.

Key Responsibilities:

  • Clinical Trial Management:

    • Plan, initiate, and manage clinical research projects from start to finish.

    • Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.

    • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.

    • Provide oversight on the recruitment, enrollment, and monitoring of clinical trial subjects.

    • Manage relationships with clinical research organizations (CROs), investigators, and external vendors.

  • Team Leadership:

    • 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 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.

    • 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 clinical trial 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 clinical trial 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 to ensure timely completion.

    • Oversee resource allocation, including personnel, equipment, and materials.

  • Collaboration and Communication:

    • 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.

    • Resolve any issues related to clinical trial execution and provide solutions.

  • Continuous Improvement:

    • Identify areas for process improvement in clinical trial execution and management.

    • Implement best practices to optimize research efficiency and compliance.

Qualifications:

• 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.

• In-depth knowledge of clinical trial management, regulatory requirements, and GCP.

• 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. Strong problem-solving and decision-making abilities.

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

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