Study Start Up Lead

vor 1 Woche

Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

General Description:

  • Drives, manages and leads all aspects of clinical study start up, from submission to site activation, Including Substantial amendment/modification activities on more than one study and/or multiple countries within the region.
  • Accountable for participating country SSU study deliverables and coordinates activities at local level, ensuring delivery of SSU according to agreed commitments.
  • Coordinates the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans for study start up activities.
  • May work independently or under the supervision of a more experienced SSU Lead for more complex or early phase studies.
  • Demonstrates a high level of knowledge in clinical trials Startup and/or project management experience (or similar skills) with a high level of understanding of local and regional regulations and clinical trials requirements
  • Demonstrates a high level of leadership, organizational, time management and communication skills
  • Delegates and oversees clinical operations tasks to other clinical operations representatives in the team, as appropriate.
  • Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.
  • Escalation, point of contact person to next level of study oversight/governance as necessary.
  • Implements best practices and shares lessons learned with team and other colleagues, as appropriate.
  • Proactively identify potential issues and seek improvement. Takes the initiative for issue resolution within and outside Study Start Up team.
  • Drives study regional SSU metrics and KPIs.
  • Ensures alignment with the CSM (Clinical Study Manager) team for the regional SSU deliverables with the overall project goals.

Essential Functions of the job:

  • Independently or under supervision where needed (for more complex studies)l, lead country SSUs teams to the timely delivery of clinical startup component of assigned studies.
  • Be accountable for high quality and timely delivery of assigned activities, which include, but are not limited to:
  • Provides regional study start-up expertise to the study team.
  • Responsible for building regional submission strategies.
  • Responsible for developing and maintaining baseline startup timelines and plan for all EU countries and reprojecting as necessary, during the study life cycle.
  • Responsible for maintenance of SSU activities during trial life cycle.
  • Maintains close collaboration with the regional study management team in the planning, execution, maintenance of the regional study timelines, country initiation and activation strategy.
  • Activities related to preparation, coordination, and submission (initial and amendments) to CEC(s), LEC(s), and other review bodies, as applicable, during the trial, life cycle
  • Accountable for the QC/review on the content of submission packages.
  • Takes accountability for the QC/review of country/site master ICF (Informed Consent Forms) adaptations.
  • Accountable for the coordination of translations for submission and startup related documents.
  • Oversight of notifications and communications with CEC(s), LEC(s), and other review bodies, as applicable.
  • Works closely with relevant study stakeholders to ensure appropriate timely responses to CEC(s), LEC(s), and other review bodies, as applicable.
  • Collaborates with RA team for coordination of timely HA(s), CEC(s) and LEC(s) submissions as applicable.
  • Accountable for timely and accurate data entry of all relevant SSU activities in the appropriate systems (i.e. CTMS).
  • Accountable for ensuring the timely and accurate SSU documents filing, review and QC, in TMF.
  • Centralizes, captures and shares SSU lessons learned and best practices.
  • Provide regular updates and inputs regional study team meetings including kickoff meetings.
  • Lead regional startup regular meetings with country SSUs, local contract specialists, contract manager, Global Regulatory Lead, local RA Lead, CRAs and any _ad hoc_ attendees as necessary.
  • Maintains close collaboration with the contract management team to ensure the preparation, negotiation, execution and tracking of site contracts/budgets.
  • Contributes to the development and review of Clinical Operations/SSU WI/SOPs, process creation/ improvements and Workstreams.
  • Ensures inspection readiness throughout the life cycle of the study.
  • Supports and provides the oversight for the SSU team with the preparation of audits, inspections, CAPA's and Serious Breaches.
  • Performs other duties as assigned by SSU Management team.
  • Mentors, supports and trains more junior SSUL's.

Supervisory Responsibilities:
For assigned studies, indirect Supervision and oversight of SSU activities in the countries in a matrix environment.

Education Required:
Bachelor's degree (or equivalent) or higher in a scientific, clinical trial, medical or healthcare discipline* (e

g:
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