{"id":3790048,"url":"https://alion.io/job/abbott-clinical-project-lead","title":"Clinical Project Lead","company":{"id":2710,"name":"Abbott","domain":"abbott.com","url":"https://alion.io/company/abbott","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":298,"ghost_share":0.003,"stale_share":0.742,"repost_share":0.02,"time_to_fill_p50_days":29,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Macquarie Park, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-05T06:09:04Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-08T07:34:12Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"JOB DESCRIPTION:\nAbout Abbott\nAbbott 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.\nWorking at Abbott\n\nAt 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:\nCareer development with an international company where you can grow the career you dream of .\nA 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.\nA 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.\nOur 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.\nThis is a 12 months contract opportunity based in Sydney \nPrimary Responsibilities:\nCore Job\nCo-ordinate designated clinical study programs in the region.\nAssess the feasibility, logistics, timeframe and budget of proposed and confirmed clinical studies.\nReview study Design including the protocol and CRF as required.\nIdentify and select investigators to undertake clinical trials.\nAssist with the selection and management of CROs where required.\nCoordinate the preparation of documentation for Ethics and Governance submissions.\nCollect and maintain regulatory documentation.\nOversee device logistics and management, including device accountability\nArrange and participate in investigator meetings as required.\nNegotiate study budgets with site personnel and prepare study contracts.\nManage site payments on a quarterly basis.\nAssist in the ordering, approving labelling and packaging and distribution of clinical study supplies.\nMentor / coach CRAs including regular site visits.\nLiaise 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.\nConduct site qualification and initiation visits, routine monitoring visits, and study close-out visits as required.\nEnsure protocol compliance as well as compliance with relevant national regulations, including ICH GCP/ISO 14155.\nEnsure accurate, complete and timely collection of data on case report forms and data clarification forms.\nOrganise investigator update meetings/reports for dissemination of study updates, when appropriate\nReview and approve FCRA monitoring visit reports.\nEnsure programs meet status and compliance as per Company clinical strategies, procedures and policies.\nLiaise with key study personnel at Abbott Headquarters and/or country offices, where appropriate\nCommunicate with investigators and site staff regularly to ensure efficiency and appropriate management of studies and satisfaction of investigators.\nAssist in preparation of monthly tracking reports for project management.\nAssist in the writing and reviewing of study reports/presentations, as required.\nParticipate in the promotion of Abbott as a clinical and scientific company.\nKnowledge of OH&S responsibilities and commitment to attending relevant OH&S training\nMaintain good communication with sites through telephone calls, emails and correspondence.\nHandle and document customer complaints according to Abbott ANZ Field Event Reporting Standard Operating Procedure.\nAction any other customer complaints with relevant Abbott ANZ Business Unit.\nPerform other related functions and responsibilities as directed by Manager.\nYou 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.\nRequirements:\n>5 years’ experience in medical device industry, or combination of medical device and pharmaceutical industry, with minimum of 2 years monitoring experience.\nKnowledge of ICH GCP Guidelines and their implementation\nKnowledge of TGA regulations pertaining to clinical trials and adverse event / adverse device effect reporting requirements\nProficient in using Microsoft Office Suites ie Word, Excel, PowerPoint\nActs on opportunities for solving problems, increase business or meeting objectives before being asked or required to do so.\nEnsures accurate understanding and acts in a way that facilities open exchange of ideas and information.\nEffectively identifies, plans, schedules and co-ordinates the resources (people, material, information, time) required to accomplish goals.\nDemonstrates attention to producing a high quality end product and constantly looks for opportunities to improve work processes and results.\nThe base pay for this position is\nN/AIn specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nResearch and DiscoveryDIVISION:\nMD Medical DevicesLOCATION:\nAustralia > Macquarie Park : 299 Lane Cove RoadADDITIONAL LOCATIONS:\nWORK SHIFT:\nStandardTRAVEL:\nYes, 10 % of the TimeMEDICAL SURVEILLANCE:\nNot ApplicableSIGNIFICANT WORK ACTIVITIES:\nContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)","description_format":"text","description_chars":5443,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Australia","iso":"AU","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiovascular Devices","Diabetes Devices","Neurotech & 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