Clinical Lead

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 on a project. 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.

Responsibilities

• Manages the day-to-day clinical project team ensuring compliance of project deliverables and any mentoring required.
• Lead site identification and site selection activities.
• Prepare and attend Client Kick-Off Meetings (KOM) and present relevant clinical topics at investigator meetings.
• Drive the Clinical Management Plan (CMP) and annotated Monitoring Visit Report (MVR) development.
• Ensure the clinical team is adequately trained on project-specific requirements.
• Ensure appropriate clinical input into relevant project specific plans, guidelines or materials.
• Develop and distribute Site Initiation Visit (SIV) materials based on materials provided from the Sponsor.
• Develop and distribute Source Data Verification tools and other relevant Monitoring tools and trackers.
• Lead the clinical team to ensure all study materials are in place before SIV.
• Drive the development of project specific annotated report templates.
• Work with Project Manager and/or Regulatory Start-Up Manager to ensure Country Activation Forms and coordinate initial shipment of IP and non-IP supplies.
• Develop and implement subject recruitment strategies at the study level.
• Review MVRs in line with the annotated report within required timelines.
• Provide final approved documents to Sponsor as required and track report metrics in CTMS.
• Proactive identification of risks to clinical deliverables and development of risk management strategies.
• Oversee safety reporting processes to ensure they are in line with regulatory requirements.

Additional Responsibility for Senior Clinical Lead

• Demonstrated ability to lead and manage a team effectively, including conflict resolution, decision-making, and motivating team members.
• Experience in mentoring and training more junior clinical lead staff.
• Strategic thinking to drive studies proactively to deliver ahead of schedule.
• 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 representing the clinical lead function.
• Actively contribute to process improvements and systems review.
• Identify out of scope tasks for entire clinical team and work with PM to ensure adequate budget coverage.
• Actively contribute to clinical team efficiency to ensure clinical team realisation stays within target of 85%.

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.
• 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.
• Demonstrates an understanding of how to obtain local support to ensure compliance with local regulations.
• Excellent analytical skills to generate and accurately understand data reporting.
• Must have an in-depth understanding of multi-country clinical trial regulations as well as site monitoring practices.
• Must have an in-depth understanding of various roles and responsibilities within projects.
• 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 at this level.
• Must have a proven record of leadership and successful study management in complex MRCT studies.
• Strong leadership in cross-functional management and coordination of departments/vendors/clients.
• 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.

Knowledge, Skills, and Abilities

• Relevant knowledge and skills in the global clinical trial environment.
• Experience and skills to manage large multi-centre clinical trials at the regional or global level.
• Good level of internal and external customer-facing experience.
• Ability to build high performing and motivated clinical team.
• Self-motivated and detail-oriented.
• Ability to work confidently under pressure, manage crises effectively and maintain positive attitude despite adversity.