Clinical Project Manager Post Market Clinical Follow-up Cardiopulmonary presso Livanova

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Position Summary:

Summary of the role, purpose and essential requirements

Under limited supervision, plan, coordinate and execute Post Market Clinical Follow-up (PMCF) activities related to Cardiopulmonary (CP) in accordance with the applicable local and international regulations, Standard Operating Procedures and LivaNova’s Clinical Evaluation and Strategy.

Assist with the development of data collection strategies, preliminary project timelines, resources and budgets to ensure successful and timely product approval, and keep products on the market.

Work closely with Clinical Program Manager to recommend and implement improved methods by developing and/or modifying department procedures, systems, and in-house training that ensure compliance with regulatory requirements.

General Responsibilities:

Description of role, key tasks etc

• Ensure sponsor compliance to local and international government regulations
• Drive Health Care Professionals (HCP) and Health Care Organizations (HCO) selection, activation, management and any close-out activities including all necessary documentation
• Establish and maintain first-line contact with HCPs (mainly perfusionists)
• Prepare and give clinical presentations/trainings to HCPs and other stakeholders , as required
• Obtain/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 needed
• Assist Clinical Program Manager with the development and planning of data collection strategies, design, synopsis, and other project-related documents and tools
• Develop synopsis/protocol
• Assist with and coordinate preparation of clinical documentation for regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations
• Develop the data collection requirements (or customer surveys) based on the clinical strategy
• Oversee and provide clinical input for the design and set-up of the data collections in the Electronic Data Capture (EDC) system
• Ensure data are being collected in a timely manner, in accordance with the timelines
• Maintain accurate and up-to-date tracking (progress and timelines) of all data collections and provide regular updates during meetings
• Assist data management with data review and resolution of queries, data inconsistencies, outliers or other issues, as identified
• Work with statistics to obtain data analysis
• Interpret results and write  reports that will be used as input for Clinical Evaluations and submissions to the Notified Bodies
• Review Clinical Evaluation Plans, review and update relevant sections of Clinical Evaluation Reports, PMCF Plans and Reports
• Ensure upload of relevant project documents in LivaNova’s dedicated repository, with agreed naming conventions
• Effectively 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 updates

Skills and Experience:

• Knowledge of international regulations and guidelines (eg. EU MDR, ISO14155, MDCG).
• Working knowledge of medical terminology
• Capability and willingness to learn about the use of multiple devices
• Ability to interface effectively with medical professionals
• Strong analytical skills, with excellent attention to detail and accuracy
• Project oversight and tracking capability
• Good oral and written communication skills
• Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously
• Experience with Electronic Data Capture (EDC), electronic reporting functionalities and Clinical Trial Management Systems (CTMS)
• Demonstrated ability to perform in a dynamic and diverse team environment
• Fluency in English language (writing and speaking), additional language(s) advantageous
• Minimum 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/CRO
• Experience and/or interested in medical writing is a plus
• Knowledge of basic statistics (eg. descriptive statistics, hypothesis testing, acceptance criteria) is a plus

Education:

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 https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.