Clinical Trials Start-up/operations Associate - Macquarie Park, Australia - MSD

MSD
MSD
Verified Company
Macquarie Park, Australia

1 week ago

Olivia Brown

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Olivia Brown

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Description

Clinical Trials Start-Up/Operations Associate
-
Looking for a different challenge as an Clinical Trials Start-Up/Operations Associate **whereby you can still utilise your skills?
-
Permanent Full-time position with
competitive renumeration and
benefits

  • Location
    :Macquarie Park, Sydney
  • Modern office environment, a
    dedicated and welcoming team
-
Upskill and growth in an area your passionate about, whilst being fully supported and encouraged.

  • Join a
    trusted Global leading organisation
  • X2
    Associate Clinical Operations Manager positions available in Sydney


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

Under the oversight of the Sr.

COM, Head COMs or CRD, the person is responsible for Supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.


What You Will Do

Responsibilities include, however not limited to:

  • Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
  • Oversees and tracks clinical researchrelated payments. Payment reconciliation at study close
- out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with Sr.
COM /other roles.

  • Contribute to Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
  • Develops working knowledge of local language materials including local language Informed Consents and translations. May interact with Regulatory Authority for assigned protocols.
  • Supports country deliverables, timelines, and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
  • Contributes to the development of local SOPs.
  • Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
  • Provide support to local vendors as applicable.
  • Support local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements. Enters and updates country information in clinical and finance systems.
  • Support of local regulatory and financial compliance.
  • Acquire knowledge how to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
  • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related
- interactions with support of an experienced COM. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.

  • Contribute to initiatives and projects adding value to the business, as appropriate/required.
  • Contributes to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement as appropriate/required.
  • Contributes to COM team knowledge by sharing best practices as appropriate/required.

What You Must have

  • Experience in Clinical Research or experience in Finance/Business
  • Required: Associate Degree or equivalent Health Care related experience
  • Preferred: Bachelor's degree

Required Skills:


  • Excellent verbal and written skills, in local language and English
  • Strong coordination and organizational skills
  • Basic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study startup.
  • Ability to propose solutions to local study teams.
  • ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices
  • Able to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.

What You Can Expect

  • Work autonomously whilst being supported, encouraged and being part of a
    trusted Global leading Pharmaceutical organisation
  • Exposure to
    upskill and develop in your role
  • Flexibility and
    opening doors to other opportunities and skillsets
  • Joining a
    collaborative team of
    likeminded individuals
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation i
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