As a Team Member in the Clinical/Pre-Clinical/Bioequivalence (BA/BE) studies, your primary role will be to execute, monitor, report, and interpret clinical studies at Contract Research Organizations (CROs). You will play a crucial role in supporting various regulatory submissions, ensuring that all studies are conducted within targeted timelines, budgets, quality standards, and regulatory guidelines. Your work will also involve identifying health hazards and assessing risks associated with pharmaceuticals, chemicals, intermediates, impurities, and more.
Key Accountabilities
- Clinical Study Data Gathering:
- Understand specific regulatory requirements and project constraints to gather data for clinical study outlines. This ensures the successful, cost-effective, and timely conduct of studies and trials.
- CRO Evaluation:
- Conduct site feasibility or selection visits to evaluate CROs. Ensure that the CROs have the necessary facilities, skills, and experience to conduct clinical/bioequivalence studies as per the requirements.
- Protocol Management:
- Liaise with CROs and internal teams to prepare, review, and finalize study protocols. Ensure that protocols are approved by all relevant stakeholders, including Ethics Committees and Regulatory Authorities, within targeted timelines.
- Study Preparation:
- Ensure the procurement and dispatch of Innovator samples/RLD, and the availability of test formulations. Ensure all relevant documents (like COA, GMP statements, batch size information, etc.) are ready before study initiation.
- Study Monitoring and Auditing:
- Monitor and audit ongoing studies at CROs to ensure they meet guidelines, regulatory requirements, study-specific criteria, and project timelines.
- Project Coordination:
- Act as the project coordinator for the entire study. Liaise with internal team members, cross-functional teams, CROs, and Project Managers to align all stakeholders and ensure the successful conduct of the BE study.
Education Qualification
- M.Pharm (Master of Pharmacy)
Relevant Work Experience
- 2 years of experience in Clinical Research Operations.
Competencies/Skills
- Collaboration: Ability to work effectively with others to achieve common goals.
- Innovation: Ability to introduce new ideas and approaches to excel in work.
- Accountability: Taking responsibility for the outcomes of your work.
- Empathy: Leading with understanding and consideration of others’ perspectives.
- Agility: Ability to adapt quickly to changes and act with flexibility.
- Domain Knowledge: Strong understanding of clinical research and regulatory guidelines.
- People Management: Ability to manage and lead a team effectively.
Job Location
- Vikhroli, Mumbai, Maharashtra
