Manager Research - Clinical Trials Unit (CTU)

The Manager Research– Clinical Trials Unit works under the direction of the Director – Pharmacy & Clinical Trials Unit and is responsible for the day-to-day management of the Unit and its studies. The role oversees CTU establishment, regulatory compliance, end-to-end trial delivery, team leadership, and sponsor/CRO coordination.

1. Unit Establishment & Regulatory Licensing

• Support CTU establishment, IEC constitution, DRAP licensing and pre-opening readiness.
• Develop SOPs, documentation, training and competency programmes.
• Coordinate equipment commissioning and cold-chain qualification.

2. Research Governance, Ethics & Compliance

• Manage ethics and DRAP submissions, approvals, amendments and reporting.
• Ensure compliance with ICH-GCP, informed consent, essential documents and safety reporting requirements.

3. Clinical Trial Operations

• Lead studies from start-up to close-out, including feasibility, recruitment, scheduling and risk management.
• Monitor trial progress and ensure delivery against approved protocols and targets.

4. Sponsor, CRO & Investigational Product Management

• Serve as the operational liaison with sponsors, CROs and monitors.
• Coordinate trial agreements, budgets, monitoring visits and investigational product management with relevant departments.

5. Quality & Research Informatics

• Maintain quality, audit and DRAP/JCI inspection readiness.
• Conduct self-inspections, manage CAPA and oversee research related HIS development, testing and implementation.

6. Team Supervision & Reporting

• Supervise and develop CTU staff, manage workload and capacity, and support recruitment and performance evaluation.
• Monitor budgets, trial expenditure and portfolio performance.
• Deputise for the Director in day-to-day management of the CTU.

• MBBS, PharmD / B. Pharm, BScN or a postgraduate degree in life sciences from an HEC-recognized institution (mandatory).
• Master’s in clinical research, Bioethics, Public Health or Hospital Management (preferred).
• Current ICH-GCP certification (mandatory).

• SOCRA (CCRP), ACRP (CCRC / CCRA / CCRP) or equivalent research certification (preferred).

  Experience:

• 8+ years in clinical research, including 3–4 years in trial management/research leadership.
• Hands-on experience managing Phase I–IV interventional trials with international sponsors/CROs.
• Proven experience in DRAP submissions and inspections under the Drugs Act 1976 and Bio-Study Rules 2017.
• Experience leading research teams.

• Preferred: Experience in establishing a CTU, including ethics committee setup and SOP development

  Skills:

• ICH-GCP, Helsinki Declaration, DRAP & bioethics compliance.
• Ethics Committee operations and research governance.
• Trial feasibility, budgeting and contract support.
• Proficiency in EHR, CTMS, EDC, eTMF and REDCap.
• Essential document control, source-data verification and audit readiness.
• Team leadership, delegation and staff development.
• Strong English & Urdu communication with sponsors and CROs