Clinical Trial Manager

1 week ago

Sydney, Australia BI Australia Full time

**The Position**:
Reporting to the Clinical Research Manager (CRM), we have an exciting opportunity for a full-time Clinical Trial Manager to join our high performing team

The Clinical Trial Manager (CTM) is responsible for regional-level trial management activities for Boehringer Ingelheim trials conducted in Asia Pacific region. The role will lead studies in accordance with the protocol, ICH-GCP guidelines, corporate SOP's as well as applicable regulatory requirements.

The CTM is a key liaison between internal and external stakeholders to drive trial frontloading activities, feasibility, execution, and overall therapeutic area development strategies.

**Tasks & Responsibilities**:

- Lead drug development plan input projects, conduct trial feasibility and site selection through cross functional and external expert engagement.
- Lead and oversight on 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 regional 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.

**Why Boehringer Ingelheim?**:
Our workplace is a creative and dynamic place to be - with the future always on our minds. Your personal journey is one you can develop from the very start, with leadership that nurtures your ambition with you.

Boehringer Ingelheim offers a competitive remuneration, attractive bonus scheme, subsided health insurance, employee assistance program, development programs and career development opportunities.

Our people are the beating heart of Boehringer Ingelheim and we have been recognised as a global Top Employer for five years. We value diversity by embracing various perspectives, fostering an inclusive environment that benefits our people, patients, and communities.

**What’s next? - How to apply**:
If you would like to be part of this highly driven and successful team, please submit your CV addressing the key criteria above.

You must have the right to live and work in this location to be considered for this opportunity.

It is our policy not to accept speculative resumes from recruitment agencies.

**Position Area**:
Human Pharma

**Position Location**:
NSW

**Organization**:
Boehringer Ingelheim

**Schedule**:
Full-Time

**#LI-BI**:

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