Clinical Trial Manager, Impact - Geelong, Australia - Deakin University

Deakin University

Verified Company

Geelong, Australia

1 week ago

Posted by:

Olivia Brown

beBee Recruiter

Description

Job no: 543518

Work type:
Full-time

Location:
Geelong - City

Categories:
Administration, Research, Technical

Colocated at Barwon Health, Health Education and Research Building (HERB), Geelong City
Full time and fixed term until December 202
HEW 8 $105,612 $120, % Superannuation

Founded in 1974, Deakin is a public university in Victoria with 61,000 students across five campuses: Melbourne Burwood, Geelong Waurn Ponds, Geelong Waterfront, Warrnambool, and the online Campus.

We are a progressive and open-minded university, with the highest student satisfaction in Victoria and consistently ranked in the top 1% of the world's universities.

The Institute for Mental and Physical Health and Clinical Translation (IMPACT) is seeking to appoint a Clinical Trial Manager.

This role will provide high level strategic guidance and support to the Executive team as well as technical and administrative support to the wider IMPACT staff conducting or planning clinical trials.

The majority of IMPACT's trials are currently Investigator-initiated clinical trials testing a range of products from pharmacological to nutraceutical to behavioural and psychological interventions.

The Clinical Trial Manager will lead the development and implementation of the Institute's overarching clinical trial strategy and activities that promote high-quality clinical trials.

Your previous experience in conducting, running, or leading clinical trials and/or a Clinical Trials Unit, ideally in the areas of mental health or psychiatry, will be highly regarded.

Your key responsibilities will include:

Providing strategic guidance to the IMPACT Executive and other key stakeholders around clinical trial research direction and progress as a key priority area of the Institute.
Creating strategies for improved and integrated clinical engagement in ways that enhance the quality and clinical salience of clinical trials and provide translation pathways for new innovations including commercialisation.
Implementing appropriate systems, standard operating procedures and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
Ensuring clinical trials within IMPACT are operating in alignment with the National Standard Operating Procedures for Clinical Trials (e.g International Council for Harmonisation (ICH) Guideline for Good Clinical Practice E6 (R2) ICH-GCP) and create monitoring guidelines to aid internal audits and coordinate quality improvement activities
Reviewing and providing input for study protocol, edit specifications, data analysis plan, and final study report, when applicable, advise on the preparation of appropriate project plans for the trial projects and advise on risk assessment and mitigation.
Providing high level and daytoday guidance to trial staff in the operational elements of the clinical trial process including ethics, contracts, multiinstitution agreements, establishing of Data Safety Monitoring Boards, data management (e.g., advise on trial registration, data dictionaries, storage and data sharing policies), safety reporting and other trial related activities.
Assisting managers in oversight, record management and professional development of IMPACT Clinical Trials staff compliance training, including but not limited to; tracking completion of staff training in psychiatric and other health assessment scales, First Aid, CPR, ASIST, venepuncture, and coordinate staff training or student placements.
Acting as a coach and work with team members to facilitate growth and development by giving balanced, constructive feedback considering individual capability and team performance, in alignment with Deakin's code of conduct and core university strategies and policies that promote a safe, sustainable and productive working environment.
Liaising with MAGNET (Mental Health Australia General Clinical Trial Network), HeSANDA (The Health Studies Australian National Data Asset) program and Barwon Health's Adrian Costa Trial centre as well as other relevant external trial related partners on issues of mutual interest.
Helping develop clinical trials related commercialisation opportunities.

To be successful, you'll have:

Postgraduate qualifications in a biomedical discipline or equivalent (e.g., nursing).
Extensive experience in the coordination and management of clinical trials years) or a Clinical Trial Unit (5+ years) ideally, but not necessarily, in mental health or psychiatry.
Experience and/or qualifications in governance, management, project management and leadership.
Experience in biomedical research.
Previous project management experience in clinical trial management including knowledge. of National Clinical Trials Governance Framework (NCTGF).
Excellent interpersonal, communication and negotiation skills.
Possess excellent risk management and problemsolving skills.