Associate Clinical Project Manager

Associate Clinical Project Manager

LivaNova

Zaventem/Belgium or Munich/Germany

About the Role

A fantastic opportunity has arisen for an Associate Clinical Project Manager to join our LivaNova team in Belgium. The successful candidate will provide support to the management of the clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. He/she 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; included are 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 CRO's. Provide clinical support to Sales and Marketing Departments as required. He/she will Works 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.

Role Responsibilities

  • Coordinate project team meetings;
  • Assist Clinical Management with the development of clinical study strategies;
  • Provide input to the study design and protocol development;
  • Prepare, review, and distribute study plans, study agreements, informed consent forms, and other study materials;
  • 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;
  • Establish and maintain first-line contact with investigators and site staff;
  • Oversee and provide clinical input for the design of the Case Report Forms and electronic databases;
  • Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required;
  • Reviews and verifies adequacy of site activation documentation;
  • 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. Assists and oversees study compliance/safety including data integrity: protocol deviations, adverse events, issues etc. If applicable, collaborates with the biometrics team to implement risk based study management;
  • Helps to ensure sponsor and site compliance to domestic and international government regulations;
  • Communicate regarding the study with Livanova and participating sites on issues, questions and study updates;
  • Assist with clinical study site monitoring, as necessary and review of monitoring activity/reports;
  • Takes initiative to oversee activities of Contract Research Organizations (CRO's), if applicable;
  • Create, update, and maintain site administrative files and trial master files (electronic and/or paper);
  • Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, SciForma);
  • For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability report;
  • Coordinates and assists bio-metrics with the data review, analysis and preparation of the study reports and coordinates their deliveries;
  • Coordinates closeout of sites/study, archive study documents.

What are we looking for?

  • Knowledge of international regulations and guidelines (ISO14155/GCP), and clinical study design and implementation;
  • Working knowledge of medical terminology;
  • Capability and willingness to learn device function;
  • Ability to interface effectively with medical professionals;
  • Strong analytical and organization skills;
  • Project tracking capability;
  • Good oral and written communication skills;
  • Excellent attention to detail and accuracy;
  • Good presentation skills;
  • Experience with electronic data capture (EDC) and clinical trial management systems (CTMS);
  • Demonstrated ability to perform in a team environment;
  • Proficient with MS Office Suite;
  • Ability to travel as necessary to clinical centers to establish and manage clinical studies. Able to travel at a minimum of 25%;
  • Fluency in English language (writing and speaking), additional language(s) advantageous;
  • Minimum Bachelors/Master’s Degree in a scientific discipline, biomedical or related fields is preferred;
  • Strong experience as Clinical Research Associate or comparable position assisting/supporting clinical project management at a medical device/drug company/CRO;
  • Experience as a Project Coordinator/Manager is advantageous.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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