Senior Associate, Clinical Research

About the role

The Senior Associate, Clinical Research will support trial and site administration, regulatory start‑up, budgeting and contract management for clinical studies in India. The role works closely with investigators, finance, legal and cross‑functional teams to ensure compliance and timely delivery of study milestones.

Key responsibilities

• Track essential documents, safety reports and update clinical trial databases (CTMS) and trackers.
• Manage clinical and non‑clinical supplies, labeling requirements and coordinate translations.
• Prepare, collate, ship and archive clinical documents, assist with eTMF reconciliation and quality control.
• Support regulatory and site start‑up activities, including IRB/ERC submissions and insurance certificate tracking.
• Develop, negotiate and maintain site budgets and contracts, calculate payments and ensure compliance with financial procedures.
• Organise investigator meetings, create study memos and support local meeting logistics.

Required profile

• Fluent in local languages and business‑proficient in English with strong communication skills.
• Good understanding of global and regional clinical research guidelines (ICH‑GCP) and Good Documentation Practices.
• Effective time‑management, negotiation and conflict‑management abilities.
• Ability to work independently and proactively in a multicultural matrix environment.

Required skills

• Strong MS Excel skills.
• Proficiency with MS Office and clinical IT applications (eTMF, CTMS).
• Knowledge of ICH‑GCP and Good Documentation Practices.