Clinical Lead

2 months ago

Hanoi, Vietnam Novotech Asia Full time

**Responsibilities**:

- Lead site identification and site selection activities.
- Lead set up of clinical components in CTMS
- Prepare for and attend investigator meetings; may present materials.
- Develop and distribute Clinical Monitorring Plan (CMP) and update as required
- Develop and distribute Site Initiation Visit (SIV) materials.
- Develop and distribute Source Data Verification/Monitoring tools and trackers.
- Develop and distribute annotated report templates and templates for visit confirmation/follow-up letters in accordance with any Sponsor requirements.
- Review Site Activation Forms and related essential documents; assist PM and/or Regulatory Start-up Manager (RSM) with Project and Country Activation Forms as requested across regions.
- Work with PM and/or RSM to coordinate initial shipment of both IP and non IP supplies across regions. Work with PM for re-supply of IP and non-IP.
- Lead the CRA team to ensure all study materials are in place before SIV.
- Lead internal meetings/teleconferences with the CRA team.
- Ensure the clinical team are adequately trained on project-specific requirements.
- Review CTMS compliance reports for clinical project team and follow up on gaps.
- Review Monitoring Visit Reports (MVR) and follow-up letters for compliance with ICH-GCP and the CMP; provide final approved documents to Sponsor as required and track report metrics in CTMS.
- Track the resolution of follow-up issues from site visits.
- Maintain protocol deviation tracking in CTMS
- Ensure appropriate issue escalation and tracking of these to resolution, proactive identification of areas of risk, and develop risk management strategies.
- Oversee safety reporting processes to ensure in line with regulatory requirements.
- Provide guidance to CRAs and IHCRAs through mentoring.
- Oversee data collection and query resolution throughout the projects.
- Oversee and coordinate the timely review and documented reconciliations of the TMF at the indicated timepoints per the project filing plan.
- Assist PM with response to audit findings and assist the clinical team with completion of any CAPA review and documentation.
- Work with PM to manage clinical resources to ensure monitoring activities are within budget and notify the PM of any changes required or changes in scope.
- Assist PM to oversee the timely completion of site and investigator payment in accordance with the schedule detailed in the Clinical Trial Agreement.
- May perform co-monitoring visits for ensuring site quality and CRA's monitoring performance as request.
- Oversees study transition plans of CRAs, ensures filing of the transition document/checklist.
- Coordinate with PM and CRAs for Database Lock (DBL) and all close-out activities.
- Oversee site close-out activities of the CRA team

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