About the Role
The Clinical Lead (CL) and Senior Clinical Lead provide direction and guidance to multi-country clinical teams in assigned project(s), coordinate site management and monitoring activities, and provide operational leadership to achieve on-time clinical deliverables. They are accountable for developing the clinical monitoring plan, participant recruitment strategy, clinical team training and assurance of high-quality data on a clinical trial. Ensure high-quality site selection, review of monitoring visit reports, review of data management plan, oversight and management of data queries and trending/analysis across designated projects.
Responsibilities
Clinical Lead responsibilities may include, but are not limited to;
- Manages the day-to-day clinical project team ensuring compliance of project deliverables and any mentoring required for all stages of a study.
- Develop training materials for clinical teams ensuring they are adequately trained on project-specific requirements/plans.
- Ensure appropriate clinical input into relevant project specific plans, guidelines or materials (e.g. pharmacy manual, protocol deviation management plan, data management plan, eCRF guidelines, eTMF management plans, Clinical Management Plan (CMP) and annotated Monitoring Visit Report (MVR), etc.).
- Coordinate initial shipment of both Investigational Product (IP) and non-IP supplies across regions inclusive of resupply.
- Develop and implement subject recruitment strategies at the study level.
- Review MVRs, trends analyses of action items, protocol deviations. Ensure compliance by site and CRA with ICH-GCP and the CMP.
- Proactive identification of risks and development of risk management strategies within clinical scope.
- Oversee safety reporting processes to ensure they are in line with regulatory requirements.
- Commitment to ethical practices and maintaining high standards of professionalism and integrity.
Additional Responsibility for Senior Clinical Lead:
- Demonstrated ability to lead and manage a team effectively, conflict resolution, decision-making, motivating team members, especially on large global trials
- Experience in mentoring and training.
- Strategic thinking , with advanced knowledge and skills in specific therapeutic areas.
- Attend Bid Defense meetings and actively promote the clinical lead function.
- Act as a subject matter expert
- Actively contribute to process improvements.
- Identify out of scope tasks to ensure adequate budget coverage.
- Actively contribute to clinical team efficiency
Clinical Lead Qualifications & Experience:
- At least 5 years of experience as CRA (Clinical Research Associate)
- Must have performed advanced clinical monitoring tasks and site management tasks at a Senior CRA level and demonstrated effective leadership, organization, communication, problem-solving and time management skills with solid understanding of risk management principles.
- Strong understanding of clinical quality, metrics compliance and the ability to meet deadlines.
- Experienced in coaching and mentoring clinical teams.
- Solid communication skills with fluency in both verbal and written English.
- Good understanding of GCP and applicable policies, confidently utilising available sources of information.
- Demonstrates an understanding of how to obtain local support to ensure compliance with local regulations.
- Excellent analytical skills, understand data reporting using the relevant system(s).
- In-depth understanding of multi-country clinical trial regulations as well as site monitoring practices.
- In-depth understanding of roles and responsibilities within projects to effectively ensure timely delivery clinical milestones.
- Excellent problem-solving skills, with proven ability to identify/manage risks at both site and regional levels.
Additional Requirements for Senior Clinical Lead
- At least 3 years’ experience as Clinical Lead (or equivalent role) with 5 years preferred.
- Proven record of leadership and successful study management in complex MRCT (Multi-Regional Clinical Trial) studies with high number of sites/subjects and large clinical team (CRA, IHCRA and clinical support roles).
- Strong leadership in cross-functional management, coordination and solving of issues.
- Experience in coaching and mentoring (Lead CRA, Clinical Lead, or equivalent).
- Experience with attending and supporting Bid Defence meetings.
- Good understanding of project financials inclusive of contracted scope, budgeted hours, and realization.
Education
- Graduate in a clinical or life-science related field
- Master’s degree or higher level preferred
