Clinical Project Lead

1 week ago

Sydney, New South Wales, Australia beBeeLeadership Full time $130,000 - $170,000

**Job Summary**

We are seeking a seasoned Clinical Project Manager to lead local-level trial management activities for our BI trials conducted in Asia Pacific region.

The successful candidate will be responsible for leading studies in accordance with the protocol, ICH-GCP guidelines, and corporate SOP's as well as applicable regulatory requirements.

Key liaison between internal and external stakeholders to drive trial feasibility, execution, and overall therapeutic area development strategies.

Responsibilities:

  • Lead drug development plan input projects, conduct trial feasibility and site selection through cross-functional and external expert engagement.
  • Lead trial start-up activities including budget negotiation and forecasting.
  • Coordinate ethics and regulatory submissions.
  • Facilitate conduction of recruitment activities.
  • Liaise with vendors when required.
  • Assess trial team resources and ensure CRAs working on assigned trials are trained and conducting monitoring in accordance with trial and company requirements.
  • Ongoing oversight of trial operations during recruitment and maintenance phases.
  • Actively participate in global teleconferences and meetings as required.
  • Arrange and conduct regular local team meetings to align overall trial objectives.
  • Maintain and review Corporate Clinical Trial Management System with timely entry of information and periodic reviews.
  • Oversee Investigator Site File (ISF) and Trial Master File (TMF) activities conducted by CTA and CRA, through regular TMF completeness checks.
  • Prepare for and participate in trial audits and inspections.
  • Successfully execute Trial close-out activities.

Requirements:

  • Tertiary qualifications in biological, health or medical sciences, pharmacy, nursing, or medicine.
  • Postgraduate qualifications highly regarded.
  • 4-6 years research experience along with project management experience and 2+ years' experience as a CRA in Australia/New Zealand or demonstrated functional knowledge of local regulations if equivalent international experience.
  • Project Management/Leadership experience - Experience leading a clinical project team consisting of internal and external stakeholders.

What We Offer:

A competitive remuneration, attractive bonus scheme, health insurance, employee assistance program, development programs and career development opportunities.

Diversity and Inclusion:

Boehringer Ingelheim is a global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and foster an inclusive environment which benefits our people, patients, and communities.

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