Job Description

The Clinical Lead (CL) 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. They do this by ensuring high quality site selection, review and approval of monitoring visit reports, review of data management plan, resolution of data queries and trending/analysis of protocol compliance.

Major 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 CRAs have strong understanding of the CMP and are compliant with (MVR) timelines. Update CMP, as required.
• Ensure the clinical team is adequately trained on project-specific requirements.
• 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, etc.).
• Develop and distribute Site Initiation Visit (SIV) materials based on materials provided from the Sponsor. Ensure CRA team’s understanding of clinical trial protocol and procedures prior to first SIV.
• Develop and distribute Source Data Verification tools and other relevant Monitoring tools and trackers for use by CRA prior to SIV.
• Lead the clinical team to ensure all study materials are in place before SIV.
• Drive the Development of project specific annotated report templates in accordance with any Sponsor requirements while ensuring CRAs have good understanding of project specific requirements prior to first visit type.
• Work with Project Manager (PM) and/or Regulatory Start-Up Manager (RSM) for Project to ensure Country Activation Forms and other relevant clinical documents across regions and coordinate initial shipment of both Investigational Product (IP) and non-IP supplies across regions inclusive of re-supply.
• Participate in client calls to lead the discussion on clinical deliverables (e.g. progress and risk) and relevant mitigation plans.
• Lead internal meetings/teleconferences with the clinical team.
• Prepare site newsletters/emails and key communications.
• Develop and implement subject recruitment strategies at the study level.
• Supervise and support CRAs to discuss subject recruitment strategies with sites, update recruitment projections, and improve site productivity.
• Oversight of Clinical Trial Management System (CTMS) for Action Items, protocol deviations, monitoring visits, and recruitment planning. Regularly pull compliance reports and ensure appropriate visit forecasting for next 3 months.
• Review MVRs in line with the annotated report within required timelines. Check for trends in action items, protocol deviations and ensure timely closure. Ensure compliance by site and CRA with ICH-GCP and the CMP.
• Provide final approved documents to Sponsor as required and track report metrics in CTMS ensuring compliant metrics.
• Share best practices within clinical team.
• Proactive identification of risks to clinical deliverables and development of risk management strategies within clinical scope.
• Oversee safety reporting processes to ensure they are in line with regulatory requirements.
• Oversee data collection and query resolution throughout the project while identifying issue/query trends with Data Management (DM) team collaboration resulting in assessment of additional training to CRAs or sites.
• Coordinate with PM, DM and CRAs for data cleaning, data verification backlog and Database Lock (DBL) throughout the project.
• Work with PM and Project Specialist (PS) to co-ordinate Trial Master File (TMF) Health Check including Health Check for KOM and follow up at subsequent timepoints to ensure TMF quality issues are completed in accordance with project TMF filing plan.
• Work with clinical team under guidance of PM with responses to relevant clinical audit findings and assist the clinical team with completion of any CAPA review/documentation.
• Work with PM to manage clinical resources to ensure monitoring activities are within budget notifying the PM of any changes required or changes in scope. Identify out of scope tasks for clinical lead function and work with PM to resolve.
• Perform onsite risk-based accompanied visit assessments (RBAVA) to ensure site quality and CRA’s monitoring performance in CL own country, if required.
• Oversee CRA transition including filing of the transition documentation.
• Oversee site close-out activities of the CRA team at end of trial.
• Commitment to ethical practices and maintaining high standards of professionalism and integrity.

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 in a fast and dynamic environment.
• 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.
• Use of excellent analytical skills to generate and accurately understand data reporting using the relevant clinical trial management system(s).
• 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 to effectively coordinate communication and ensure timely delivery clinical milestones.
• Excellent problem-solving skills, with proven ability to identify/manage risks at both site and regional levels.

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.