Head Clinical Operations

This role is for one of the Weekday's clients

Min Experience: 10 years

Location: Mumbai

JobType: full-time

The Head of Clinical Operations will provide strategic, operational, and scientific leadership across the organization’s clinical research portfolio, with a strong focus on Bioavailability (BA) and Bioequivalence (BE) studies. This role is responsible for overseeing end-to-end clinical operations, ensuring regulatory compliance, operational excellence, cost efficiency, and timely delivery of high-quality clinical studies.

As a senior leader, you will drive clinical strategy, build and mentor high-performing teams, collaborate with cross-functional stakeholders, and represent clinical operations in regulatory and client-facing interactions. The role demands deep expertise in clinical studies, strong people leadership, and the ability to scale operations in a regulated and fast-evolving environment.

Requirements:
Key Responsibilities

• Lead and oversee the planning, execution, and delivery of BA/BE and other clinical studies, ensuring adherence to approved protocols, timelines, budgets, and quality standards.
• Define and implement clinical operations strategy aligned with organizational goals and regulatory requirements.
• Ensure full compliance with ICH-GCP, CDSCO, US FDA, EMA, and other global regulatory guidelines applicable to clinical research.
• Provide oversight of site selection, feasibility, patient recruitment, study conduct, monitoring, and study close-out activities.
• Establish and optimize SOPs, workflows, and quality systems to improve operational efficiency and audit readiness.
• Lead, mentor, and develop clinical operations teams, including clinical project managers, CRAs, study coordinators, and support staff.
• Oversee vendor and CRO management, including contract negotiations, performance monitoring, and cost control.
• Collaborate closely with regulatory affairs, biostatistics, data management, pharmacovigilance, and medical teams to ensure seamless study execution.
• Monitor key performance indicators (KPIs) and proactively identify and mitigate operational risks.
• Support regulatory inspections, audits, and client audits, serving as a key point of contact for clinical operations.
• Contribute to business development activities by providing operational inputs, feasibility assessments, and study timelines for proposals.

Key Skills & Competencies

• Extensive hands-on experience in clinical operations with strong exposure to BA/BE studies.
• In-depth understanding of clinical trial regulations, guidelines, and quality standards.
• Proven leadership and people management skills with the ability to build and scale teams.
• Strong project management, problem-solving, and decision-making capabilities.
• Excellent stakeholder management and communication skills.
• Ability to manage multiple studies and priorities in a high-compliance environment.
• Strategic mindset with strong execution focus.

Ideal Candidate Profile

• 10–25 years of progressive experience in clinical research or clinical operations.
• Demonstrated leadership experience in managing large clinical teams and complex studies.
• Prior experience in CROs, pharmaceutical companies, or clinical research organizations is preferred.