Clinical Projects Lead

     

JOB DESCRIPTION:

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.

Primary Responsibilities:

Core Job

• Co-ordinate and monitor the designated clinical study programs in the region.
• In collaboration with Manager, determine which key products will be investigated.
• Assess the feasibility, logistics, timeframe and budget of proposed and confirmed clinical studies.
• Design the study protocol and CRF for local clinical trials 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.
• 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.
• Allocate and manage the budget for clinical trials.
• 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.

Quality, Safety and Environmental

• Attend regular departmental meetings with relevant manager/supervisor to build in continuous feedback mechanisms.
• Meet the requirements of ISO by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.
• Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures, and work practices with the intent of preventing or minimising accidental exposures to self, colleagues and/or the environment. 
• Ensure any PPE provided by the Abbott is worn.
• Report any accidents or incidents within 24 hours through Donesafe and notify your manager.

Conduct

• Ensure all activities carried out by self and others are in accordance with legislative employment policies, health & safety requirements and global policy.
• Promote a standard of excellence for quality and customer focus at Abbott.
• Uphold the Abbot Code of Business Conduct.
• Live our Abbott Values – Pioneering, Achieving, Caring, Enduring.
• Maintain up-to-date knowledge of Abbott standard operating procedures and policies and always ensure compliance.
• Ensure your Company related activities comply with relevant Acts, legal demands and ethical standards.

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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Research and Discovery

     

DIVISION:

MD Medical Devices

        

LOCATION:

Australia > Macquarie Park : 299 Lane Cove Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)