Job Description
Job Purpose:
- 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.
Minimum Requirements:
- Matric/ Grade 12
- 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
Main 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
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