Senior Programs and Operations Manager | Prudent HR Solutions

Job Description

• The Senior Programs and Operations Manager is responsible for providing strategic leadership and operational oversight to ensure the successful planning, execution, and delivery of clinical trial programs.
• This role bridges program management and operational excellence by driving cross-functional alignment, optimizing resources, and ensuring compliance with regulatory and quality standards.
• The position is accountable for managing complex clinical programs, streamlining operational processes, and supporting organizational goals to deliver high-quality outcomes on time and within budget.

Key Responsibilities
Program Management

• Lead the planning, execution, and delivery of multiple clinical trial programs across all phases.
• Oversee project timelines, budgets, and milestones, ensuring adherence to contractual and regulatory requirements.
• Partner with cross-functional teams (Clinical Operations, Data Management, Biostatistics, Regulatory, etc.) to ensure seamless program execution.
• Identify risks, issues, and dependencies; implement mitigation strategies proactively.

Operations Management

• Develop and optimize operational processes to improve efficiency, quality, and compliance across clinical programs.
• Manage resource allocation and workload balancing across projects and teams.
• Establish and monitor key performance indicators (KPIs) to track program and operational performance.
• Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs.

Leadership & Stakeholder Management

• Act as the key point of contact for sponsors, senior leadership, and cross-functional stakeholders.
• Mentor, guide and drive performance of Heads of Departments and operations staff to build organizational capability.
• Contribute to strategic planning, business development initiatives, and continuous improvement efforts.
• Communicate program progress, risks, and operational updates to executive leadership.

Requirements
Key Skills & Qualifications

• Tertiary Qualification in Project Management/ Healthcare or related field
• Experience in clinical trials, with at least 3+ years in a senior project or operations management role.
• Strong knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements will be an added advantage
• Demonstrated experience in managing complex, multi-phase programs.
• Proven leadership skills with experience in mentoring, managing and driving performance of cross-functional teams.
• Strong financial and resource management skills.
• Excellent communication, negotiation, and stakeholder management abilities.
• Ability to thrive in a fast-paced, matrixed environment.