DGM - Clinical Operations

Company Description Accutest Research Laboratories Pvt. Ltd. is an independent Indian clinical research organization (CRO) specializing in end-to-end drug development and testing services since 1998.

The organization supports pharmaceutical partners globally with bioequivalence, clinical development, and biologics services, backed by advanced clinical facilities and bio-analytical laboratories in Navi Mumbai and Vadodara. Accutest’s sites are accredited by leading regulatory authorities, including DCGI, US FDA, ANVISA, EMA, WHO, NPRA, and OECD-GLP, and have successfully undergone 130+ regulatory inspections. An experienced multidisciplinary team, robust data security and project controls, and a large volunteer pool enable efficient, high-quality studies from BA/BE to Phase II–IV clinical trials.

Team members join a culture that emphasizes collaboration, innovation, regulatory excellence, and meaningful impact on global healthcare.

Role Description The DGM – Clinical Operations will oversee the planning, execution, and monitoring of clinical studies, including BA/BE and Phase II–IV trials, ensuring alignment with regulatory requirements and internal quality standards. This full-time, on-site role based in Navi Mumbai involves leading cross-functional clinical teams, coordinating with investigators, sponsors, and internal stakeholders, and managing timelines, budgets, and study resources.

The position is responsible for reviewing and implementing clinical protocols, supervising site start-up and operational activities, and resolving operational issues in a proactive, data-driven manner. The DGM – Clinical Operations will also establish and refine clinical operations processes, support audits and inspections, and contribute to strategic planning for new studies and capabilities. Regular reporting on study progress, risk management, and performance metrics to senior leadership is a key part of the day-to-day responsibilities.

Qualifications

• Strong Clinical Operations experience, including oversight of multi-center studies and operational process improvement.
• Demonstrated Research and Clinical Trials expertise, with hands-on involvement in BA/BE and Phase II–IV clinical studies.
• Proficient Project Management skills to manage timelines, budgets, resources, stakeholders, and risk across complex clinical programs.
• Solid understanding of Protocol design, review, implementation, and compliance with ICH-GCP and relevant regulatory guidelines.
• Advanced degree in life sciences, pharmacy, medicine, or a related field; prior leadership experience in a CRO or pharmaceutical environment is strongly preferred.
• Excellent analytical, problem-solving, and decision-making abilities, with strong written and verbal communication skills.
• Proven ability to lead and mentor multidisciplinary teams, collaborate with internal and external partners, and support regulatory inspections.
• Familiarity with clinical data management systems, quality management processes, and documentation standards; exposure to biologics