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Job Description
Job Requirements:
- Ph.D., M.S., M.Sc, B.Sc or equivalent in a relevant scientific discipline (e.g., pharmacology, toxicology, biology).
- Minimum of 7-10 years of experience in clinical research
- Proven track record of successfully managing clinical trials and programs.
- Experience with regulatory requirements for clinical research.
- Strong organizational and project management skills.
- Excellent written and verbal communication abilities.
- Proficient in data analysis and interpretation.
- Ability to lead and motivate a diverse team.
- Detail-oriented with a commitment to scientific rigor and quality
- This position may require occasional travel to CROs, scientific conferences, and regulatory meetings.
- The role is primarily office-based with potential laboratory oversight responsibilities.
- The candidate for Clinical Trials will oversee the planning, coordination, and execution of clinical research studies. This role is critical in ensuring the successful development of earlystage therapeutics through rigorous scientific investigation and regulatory compliance.
- The Manager will work closely with cross-functional teams, including research scientists, regulatory affairs, and project management, to drive the progress of clinical programs.
- Develop and implement clinical study protocols in alignment with project goals. Collaborate with scientific teams to design robust experiments and select appropriate models. Ensure study designs meet regulatory requirements and scientific standards.
- Manage day-to-day operations of clinical studies, including in vitro assays. Oversee the collection, analysis, and interpretation of clinical data. Coordinate with clients and other external partners as needed. Ensure adherence to timelines and budgets for clinical programs.
- Ensure accurate and complete documentation of all clinical activities. Prepare detailed study reports and present findings to internal stakeholders. Contribute to the preparation of regulatory submissions and scientific publications.
- Maintain compliance with all relevant regulations and guidelines, including GMP, GLP (Good Laboratory Practice). Implement and monitor quality assurance processes to ensure the integrity of study data. Liaise with regulatory bodies as needed to support clinical program requirements.
- Supervise and mentor junior staff and research associates. Foster a collaborative and innovative team environment. Identify training needs and facilitate professional development opportunities.
- Work closely with project management, regulatory affairs, and clinical development teams to ensure seamless completion of clinical phases. Communicate effectively with internal and external stakeholders to align on project objectives and timelines.
Job Requirement
Additional Information
Job Type | : | Full Time |
Experience | : | 7 - 10 years |
Location | : | Bengaluru, India |
Qualification | : |