Senior Clinical Trial Management Specialist

3 semanas atrás

São Paulo, São Paulo, Brasil Beigene Tempo inteiro

Job Summary:

We are seeking a highly skilled and experienced Clinical Trial Management Associate to join our team in a Senior Regional Clinical Trial Management Associate role.

About the Role:

As a Senior Regional Clinical Trial Management Associate, you will be responsible for supporting the Regional Clinical Study Manager in regional study delivery and ensuring that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget.

Key Responsibilities:

  • SUPPORTS regional study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget.
  • SUPPORTS the Clinical Research Associates and/or Study Start-up Specialists in country study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards.
  • APPLIES knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager.
  • SUPPORTS the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager.
  • SUPPORTS regional vendor management in addition to other regional study management activities.
  • PARTICIPATES in internal working groups, initiatives.
  • MIGHT mentor other team members.
  • PERFORMS other tasks assigned by the line manager.

Essential Functions:

  • Regional Trial Support & Collaboration
  • Acquires regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.
  • Acquires country study management experience by supporting CRAs and/or SSUSs with multiple aspects of clinical trial conduct including CTMS updates, ISF binder preparation, document collections, ICF customization, eTMF maintenance (document filing, reconciliation and review at site level or country level).
  • Knowledgeable of clinical research operations, including interpretation and implementation of regulations/ICH guidelines.
  • SUPPORTS the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, etc.).
  • SUPPORTS the Country Heads with set up and logistics of regional team meetings (agenda, minutes etc.).
  • Establishes good collaboration with key stakeholders regionally, globally and at country level (Regional Clinical Study Manager, Regional Clinical Trial Management Associate, Global Study Management Associate, Clinical Research Associates and Study Start-up Specialists).
  • As required, supports CRAs with various activities such as monitoring visit preparations, equipment management, Contract support, EC/regulatory submission preparation/tracking, TMF filing, SUSAR submission, etc.

Timelines, Planning and Execution:

  • Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists.
  • Sets up the countries and sites in the region in the appropriate systems e.g., eTMF, CTMS, etc. and makes sure information is kept up to date.
  • SUPPORTS system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region.
  • MIGHT support the local adaptation of global documents under supervision of the Regional Clinical Study Manager.
  • May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters).
  • SUPPORTS study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager.
  • SUPPORTS the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management Associate.
  • SUPPORTS the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC plan.
  • Helps resolving any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholders.
  • SUPPORTS the data cleaning activities and contributes to the follow up of outstanding information for region/country.
  • Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., best practices and lessons learned, frequently asked questions) in collaboration with the study team.
  • MIGHT assist in resolution of routine study questions from clinical trial sites.
  • MIGHT support the maintenance of information for region/country in relevant public registries (e.g., CT.gov).
  • SUPPORTS the Regional Clinical Study Manager with providing all relevant information from region/country to be included in the Clinical Study Report.

Quality:

  • SUPPORTS the identification of operational risks and works with the Regional Clinical Study Manager to mitigate them.

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