Clinical Project Manager Post Market Clinical Follow-up Cardiopulmonary

Description of role, key tasks etcEnsure sponsor compliance to local and international government regulationsDrive Health Care Professionals (HCP) and Health Care Organizations (HCO) selection, activation, management and any close-out activities including all necessary documentationEstablish and maintain first-line contact with HCPs (mainly perfusionists)Prepare and give clinical presentations/trainings to HCPs and other stakeholders , as requiredObtain/negotiate contracts with HCP or HCO (templates available, fair market value rates managed via dedicated tool)Complete/update documentation in dedicated tool to manage payments of the HCP/HCO fees.Prepare documents and submission package to ensure Ethics Committee and/or Data Privacy Clearance is obtained to collect the data, as neededAssist Clinical Program Manager with the development and planning of data collection strategies, design, synopsis, and other project-related documents and toolsDevelop synopsis/protocolAssist with and coordinate preparation of clinical documentation for regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentationsDevelop the data collection requirements (or customer surveys) based on the clinical strategyOversee and provide clinical input for the design and set-up of the data collections in the Electronic Data Capture (EDC) systemEnsure data are being collected in a timely manner, in accordance with the timelinesMaintain accurate and up-to-date tracking (progress and timelines) of all data collections and provide regular updates during meetingsAssist data management with data review and resolution of queries, data inconsistencies, outliers or other issues, as identifiedWork with statistics to obtain data analysisInterpret results and write reports that will be used as input for Clinical Evaluations and submissions to the Notified BodiesReview Clinical Evaluation Plans, review and update relevant sections of Clinical Evaluation Reports, PMCF Plans and ReportsEnsure upload of relevant project documents in LivaNova’s dedicated repository, with agreed naming conventionsEffectively communicate with LivaNova management, HCPs and other internal (eg. medical experts, sales & marketing, field specialists, complaint handling, legal, data privacy) and external (eg. distributors) stakeholders on issues, questions and/or study updatesSkills and Experience:Knowledge of international regulations and guidelines (eg. EU MDR, ISO14155, MDCG).Working knowledge of medical terminologyCapability and willingness to learn about the use of multiple devicesAbility to interface effectively with medical professionalsStrong analytical skills, with excellent attention to detail and accuracyProject oversight and tracking capabilityGood oral and written communication skillsAbility to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneouslyExperience with Electronic Data Capture (EDC), electronic reporting functionalities and Clinical Trial Management Systems (CTMS)Demonstrated ability to perform in a dynamic and diverse team environmentFluency in English language (writing and speaking), additional language(s) advantageousMinimum prior work experience of 5+ years as a (Associate) Project Manager or comparable position assisting/supporting clinical project management at a medical device/drug company/CROExperience and/or interested in medical writing is a plusKnowledge of basic statistics (eg. descriptive statistics, hypothesis testing, acceptance criteria) is a plusEducation:Minimum Bachelor’s Degree in the medical, biological and/or bio-engineering field Travel Requirements:This position requires limited business travel (up to 10%) Valuing different backgrounds:LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification. Notice to third party agencies:Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.Beware of Job Scams:Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on, and check that all recruitment emails come from an @livanova.com email address.