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.
Skills Required
- 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
- 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
What We Do
PLLP offers accounting, business development, and legal consultancy services, with over 50 years of experience helping to transform distressed businesses into profitable ventures.
