Associate Manager, Clinical
Labcorp Drug Development
Wellington, New Zealand
2h ago

Job Overview :

Join Labcorp and our FSPx department, sponsor dedicated.

We are looking for an Associate Manager Clinical Research to be based in Sydney.

This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH / GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Responsibilities include, but are not limited to :

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
  • Responsible for project management of the assigned studies : pro-actively plans, drives and tracks execution and performance of deliverables / timelines / results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for performance for assigned protocols in a country in compliance with ICH / GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
  • o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and / or functional vendor and internal management as needed.

    o Performs Quality control visits as required

  • Leads local study teams to high performance : trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
  • Responsible for creating and executing a local risk management plan for assigned studies
  • Ensures compliance with CTMS, eTMF and other key systems in assigned studies
  • Escalates as needed different challenges and issues to TA Head / CRD / CQM and or CTT (as appropriate)
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
  • Serves local business needs as applicable in his / her country (If delegated can sign contracts and manage budgets)
  • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his / her studies.
  • GHH to be consulted as needed.

  • As a customer-facing role, this position will build business relationships and represent company with investigators
  • Shares protocol-specific information and best practices across countries clusters
  • Education / Qualifications :

    Required :

  • University / college degree (life science preferred) or certification in a related allied health
  • profession (i.e. nursing, medical or laboratory technology) from an appropriately

    accredited institution

    Preferred :

  • Master or other advanced degree
  • PMP certification
  • Experience : Minimum Required :

    Minimum Required :

    Minimum of five (5) years of relevant clinical research experience in a pharmaceutical

    company / CRO.

    In lieu of the above requirement, candidates with (a) six (6) years supervisory experience

    in a heath care setting and (b) five (5) years clinical research experience including one (1)

    years of project management experience (international clinical trial management

    experience preferred) in the pharmaceutical or CRO industries will be considered

    Preferred :

    Regional project management experience

    On the Job Experience :

    Working knowledge of ICH Guidelines and GCP including international regulatory

    requirements for the conduct of clinical development programs.

    Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)

    Experience managing projects in a matrix and virtual environment

    Excellent communication, planning and organizational skills

    Demonstrated ability to lead by example and to encourage team members to seek solutions

    independently

    Demonstrated ability to handle multiple competing priorities and to utilize resources

    effectively

    Demonstrated ability to inspire effective teamwork and motivate staff within a matrix

    system

    Financial awareness and ability to actively utilize financial tracking systems

    Working knowledge of project management processes

    Ability to work independently and mentor junior project team members

    Ability to negotiate and liaise with clients in a professional manner

    Ability to present to staff at all levels

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