Assistant Manager - Clinical Trials (Personal Care Products)

Job Summary:

Assistant Manager Clinical Trials will lead and manage clinical trials and research studies, ensuring that they are completed on time, within budget, and in compliance with regulatory standards. The assistant manager will supervise research teams, collaborate with cross-functional departments, and provide strategic direction for

clinical research activities.

Key Responsibilities:

1. 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, enrolment, and monitoring of

clinical trial subjects.

• Manage relationships with clinical research organizations (CROs),

investigators, and external vendors.

2. 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.

3. 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.

4. 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.

5. Data Management and Reporting:

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

stakeholders.

6. 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.

7. 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.

8. Continuous Improvement:

• Identify areas for process improvement in clinical trial execution and

management.

• Implement best practices to optimize research efficiency and

compliance.