Associate Clinical Project Manager (Medical Device)

Join us today and make a difference in people's lives!
 

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.  The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .”  LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

The Associate Clinical Project Manager will assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts.  Duties will include assisting with the study design, coordinating, managing and working with  clinical support resources such as a clinical research monitors/clinical research associates, Field Clinical Managers, Field Clinical Engineers, and CROs.

The Associate Clinical Project Manager will also provide clinical support to Sales and Marketing Departments and work closely with Clinical Management 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

• Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools.

• Oversee and provide clinical input for the design of the Case Report Forms and electronic databases.

• Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products.

• Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation.

• Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required.

• Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports.

• Assure clinical studies are adequately managed to meet the protocol objectives and schedules.

• If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies.

• Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified.

• Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds.

• Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable.

• Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines.

• Effectively communicate with Livanova study management, participating sites, and any vendors on issues, questions and/or study updates.

• Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times.

• Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC).

• For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery.  Maintain device accountability plan and report.

• Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries.

Minimum Skills & Experience

• Minimum experience of 4+ years as a Clinical Project Manager or comparable position assisting/supporting clinical project management at a sponsor organization (medical device preferred), clinical research site, or CRO

• Knowledge of international regulations and guidelines (ISO14155/GCP), and clinical study design and implementation.

• Working knowledge of medical terminology and able to interface effectively with medical professionals

• Strong analytical and organization skills, with excellent attention to detail and accuracy

• Project oversight and tracking capability

• Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously

• Experience with electronic data capture (EDC) and clinical trial management systems (CTMS)

• Demonstrated ability to perform in a team environment

Education

• Minimum Bachelor’s Degree in the medical, biological and/or bio-engineering field

Travel Requirements

• This position requires regular business travel up to 25% or more of the time.

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $90,000 - $110,000 + discretionary annual bonus. Pay ranges may vary by location.

Employee benefits include:

• Health benefits – Medical, Dental, Vision

• Personal and Vacation Time

• Retirement & Savings Plan (401K)

• Employee Stock Purchase Plan

• Training & Education Assistance

• Bonus Referral Program

• Service Awards

• Employee Recognition Program

• Flexible Work Schedules

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.