Job Summary

The Manager, Clinical Research Regulatory will lead the planning, implementation, and oversight of clinical research regulatory functions at the Brain & Mind Institute (BMI) at Aga Khan University (AKU). This role ensures scientific integrity, regulatory compliance, and ethical conduct of research studies, particularly those focusing on brain and mental health. The Manager will develop and enforce robust regulatory systems and quality assurance procedures that align with Good Clinical Practice (GCP), institutional policies, and local/international regulations. The incumbent will also manage frameworks, supervise site monitors, collaborate with investigators, and ensure that BMI’s clinical research consistently meet internal quality standards and external regulatory expectations.

Responsibilities

• Regulatory Oversight & Compliance
• Ensure ethical and regulatory compliance in the conduct of studies, with reference to both local and global standards including, ethics committees, regulatory agencies, ICH-GCP, FDA, EMA, and WHO standards.
• Ensure that Trials Master Files (TMF) and Investigator Site Files (ISF) and site essential documents are maintained in accordance with ICH-GCP guidelines, reviewing regularly to ensure completeness, certified copies (signed and stamped) and up to date documentation. Implement corrective processes as necessary.
  Guide and support protocol and associated documentation submissions to ethics and regulatory bodies, including amendments and renewals.

Clinical Regulatory & Site Management

• Lead development of study-specific regulatory plans, incorporating risk-based regulatory, detailing site regulatory strategies, frequency, and methodologies, tailored to the needs of specific studies and regulatory requirements.
• Support the conduct of site qualification, initiation, regulatory, and close-out visits to evaluate study progress and ensure adherence to the study protocol.
• Perform regulatory activities such as Source Data Verification (SDV), Source Data Review (SDR), Informed Consent Form (ICF) review, case report forms (CRFs) review, both for data accuracy and protocol adherence, and ensure Corrective and Preventive Actions (CAPA) are implemented by the study team.

Quality Assurance & Control (QA/QC)

• Develop SOPs for regulatory, audits, documentation, and reporting.
• Conduct internal audits and implement corrective/preventive actions (CAPAs).
• Ensure consistency of data management and integrity of trial results. Liaise with data management team on data quality and in the timely resolution of data queries.

Research Ethics & Participant Safety and Welfare

• Ensure informed consent processes are compliant and culturally appropriate.
  Work with the study team to ensure protocol adherence in participant recruitment, retention, safety and welfare.
• Capacity Building & Site Trainings
• Support the onboarding and training of clinical research regulatory team.
• Develop training modules on GCP, regulatory updates, and SOPs and support conduct of aligned trainings.
• Conduct routine performance evaluations and coaching for assigned staff.

Stakeholder Engagement

• Serve as a liaison with sponsors, CROs, and collaborative partners.
• Support coordination of investigator meetings, site visits, and study review meetings.

Risk Assessment, Management & Escalation Protocols

• Conduct a comprehensive risk assessment of various studies, categorizing risks according to severity, likelihood/probability and detectability.
• Discuss identified risks with the Core-study Coordination Team to develop risk anticipation strategies and mitigation plans.

Requirements

• A master’s degree in a scientific or relevant field is preferred. A bachelor’s degree with commensurate experience may be considered. Possible streams include: Clinical Research, Public Health, Pharmacy, Health Sciences, Neuroscience, Psychology or equivalent field.
• Expert knowledge of clinical research standards and regulations including ICH GCP, Declaration of Helsinki, FDA CFR, Good Documentation Practices, and other relevant in-country regulations required.
• Knowledge of risk-based regulatory strategies and risk mitigation plans.
• Training in ICH-GCP and research ethics is essential.

Relevant Experience.

• Minimum 4 years in clinical research, with at least 3 years in clinical regulatory, QA/QC, or regulatory compliance.
• Experience conducting studies in neuroscience, mental health, cognitive disorders and/or global health is highly desirable.
• Demonstrated success in managing audits, inspections, and regulatory engagements.
• Familiarity with both local (e.g., PPB, NAFDAC) and international (e.g., FDA, EMA) regulations
• Ability to mentor other clinical operations/regulatory staff is required.
• Experience working collaboratively with people of diverse educational and cultural backgrounds and maintaining a high standard of professional conduct, as a representative of AKU, is required.
• Experience with electronic document management systems as well as electronic data capture systems is required.
• Excellent computer skills with capability to utilize digital tools to conduct remote and risk-based regulatory.

Personal Characteristics

• Strong interpersonal skills and ability to work effectively with outside stakeholders, collaborators, subordinates and functional peer groups at various management levels.
• The ability to work on problems of high complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is highly desirable.
• Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required.
• Being detail-orientated, with the ability to work independently on multiple projects/tasks with overlapping schedules and priorities is highly desirable.
• Excellent oral and written communication skills are required. This includes the ability to conduct presentations of technical information concerning specific project aspects as well as being an effective trainer.