Senior Site Manager / Senior Clinical Research Associate, GCO Malaysia

Synthes GmbH

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  • Date de publication :

    12 mars 2024
  • Taux d'activité :

    100%
  • Type de contrat :

    Durée indéterminée
  • Lieu de travail :

    Fully

Senior Site Manager / Senior Clinical Research Associate, GCO Malaysia

Position Summary:


  • A Site Manager II (SM II) serves as the primary contact point between the Sponsor and the Investigational
    Site. A Site Manager II is assigned to trial sites to ensure inspection readiness through compliance with the
    clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and
    applicable regulations and guidelines from study start-up through to site closure. Responsibilities may
    include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site
    initiation, on-site and remote monitoring and close-out activities. Site Manager will partner with the Local
    Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site
    management while performing trial related activities for assigned protocols. A Site Manager II may
    contribute to process improvement, training and mentoring of other Site Managers.

Key Responsibilities: 


  • Acts as primary local company contact for assigned sites for specific trials.

  • May participate in site feasibility and/or pre-trial site assessment visits

  • Attends/participates in investigator meetings as needed.

  • Responsible for executing activities within site initiation and start-up, preparation and conduct of site
    monitoring (including remote monitoring), site management (by study specific systems and other
    reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.

  • Responsible for the implementation of analytical risk based monitoring model at the site level and to
    work with site to ensure timely resolution of issues found during monitoring visits.

  • Ensures site staff are trained and the corresponding training records are complete and accurate at any
    time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in
    shortest possible timeframe.

  • Contributes to site level recruitment strategy and contingency planning and implementation in
    partnership with other functional areas.

  • Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial
    conduct.

  • Ensures that clinical drug supplies are appropriately used, handled and stored and returns are
    accurately inventoried and documented.

  • Arranges for the appropriate destruction of clinical supplies.

  • Ensures site staff complete data entry and resolve queries within expected timelines.

  • Ensures accuracy, validity and completeness of data collected at trial sites

  • Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs)
    are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs,
    ensures that they are consistent with all data collected and with the information in the source
    documents.

  • Maintains complete, accurate and timely data and essential documents in relevant systems utilized for
    trial management.

  • Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter
    in accordance with the SOPs. Promptly communicates relevant status information and issues to
    appropriate stakeholders.

  • Reviews study files for completeness and ensures archiving retention requirements are met, including
    storage in a secure area at all times.

  • Collaborates with LTM for documenting and communicating site/study progress and issues to trial
    central team.

  • Attends regularly scheduled team meetings and trainings.

  • Complies with relevant training requirements. Act as local expert in assigned protocols. Develops
    therapeutic knowledge sufficient to support role and responsibilities.

  • Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality
    Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and
    other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).

  • Prepares trial sites for close out, conduct final close out visit.

  • Tracks costs at site level and ensure payments are made, if applicable.

  • Establishes and maintains good working relationships with internal and external stakeholders in
    particular investigators, trial coordinators and other site staff.

  • May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as
    required/appropriate.

  • Acts as a point of contact in site management practices.

  • May be assigned as a coach and mentor to a less experienced site manager.

  • May contribute to process improvement and training.

  • Leads and/or participates in special initiatives as assigned.

  • May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter
    Expert”.

Principal Relationships:


  • Primary Reporting Structure: Reports to a functional manager

  • Primary interfaces: Functional Manager, CTA, LTM and CTM.

  • Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Quality & Compliance
    Manager/Specialist, Training Manager, Contracts & Grants, Local Drug Safety Officer (where required) and
    Site Manager team.

  • External Interfaces: Investigators and their delegates at site (trial site personnel).


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