Clinical Lead

2 weeks ago


Singapore 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/followup letters in accordance with any Sponsor requirements.
  • Review Site Activation Forms and related essential documents; assist PM and/or Regulatory Startup 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 resupply of IP and nonIP.
  • 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 projectspecific requirements.
  • Review CTMS compliance reports for clinical project team and follow up on gaps.
  • Review Monitoring Visit Reports (MVR) and followup 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 followup 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 comonitoring 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 closeout activities.
  • Oversee site closeout activities of the CRA team


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