Clinical Project Lead

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of .

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

This is a 12 months contract opportunity based in Sydney

Primary Responsibilities:

Core Job

Co-ordinate designated clinical study programs in the region.

Assess the feasibility, logistics, timeframe and budget of proposed and confirmed clinical studies.

Review study Design including the protocol and CRF as required.

Identify and select investigators to undertake clinical trials.

Assist with the selection and management of CROs where required.

Coordinate the preparation of documentation for Ethics and Governance submissions.

Collect and maintain regulatory documentation.

Oversee device logistics and management, including device accountability

Arrange and participate in investigator meetings as required.

Negotiate study budgets with site personnel and prepare study contracts.

Manage site payments on a quarterly basis.

Assist in the ordering, approving labelling and packaging and distribution of clinical study supplies.

Mentor / coach CRAs including regular site visits.

Liaise with the CRAs to ensure that the documentation for each clinical study is complete, thorough and transmitted in accordance with set schedules, including the reporting & follow up of Serious Adverse Events (SAE) according to Abbott SOPs and regulatory requirements.

Conduct site qualification and initiation visits, routine monitoring visits, and study close-out visits as required.

Ensure protocol compliance as well as compliance with relevant national regulations, including ICH GCP/ISO 14155.

Ensure accurate, complete and timely collection of data on case report forms and data clarification forms.

Organise investigator update meetings/reports for dissemination of study updates, when appropriate

Review and approve FCRA monitoring visit reports.

Ensure programs meet status and compliance as per Company clinical strategies, procedures and policies.

Liaise with key study personnel at Abbott Headquarters and/or country offices, where appropriate

Communicate with investigators and site staff regularly to ensure efficiency and appropriate management of studies and satisfaction of investigators.

Assist in preparation of monthly tracking reports for project management.

Assist in the writing and reviewing of study reports/presentations, as required.

Participate in the promotion of Abbott as a clinical and scientific company.

Knowledge of OH&S responsibilities and commitment to attending relevant OH&S training

Maintain good communication with sites through telephone calls, emails and correspondence.

Handle and document customer complaints according to Abbott ANZ Field Event Reporting Standard Operating Procedure.

Action any other customer complaints with relevant Abbott ANZ Business Unit.

Perform other related functions and responsibilities as directed by Manager.

You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences.  These events may take place on an evening and/or weekend.

Requirements:

>5 years’ experience in medical device industry, or combination of medical device and pharmaceutical industry, with minimum of 2 years monitoring experience.

Knowledge of ICH GCP Guidelines and their implementation

Knowledge of TGA regulations pertaining to clinical trials and adverse event / adverse device effect reporting requirements

Proficient in using Microsoft Office Suites ie Word, Excel, PowerPoint

Acts on opportunities for solving problems, increase business or meeting objectives before being asked or required to do so.

Ensures accurate understanding and acts in a way that facilities open exchange of ideas and information.

Effectively identifies, plans, schedules and co-ordinates the resources (people, material, information, time) required to accomplish goals.

Demonstrates attention to producing a high quality end product and constantly looks for opportunities to improve work processes and results.