Project Manager Clinical Research

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Clinical Research and Medical Devices organization, based in Brussel Belgium.

Our client is a well known producer of medical devices and is operating worldwide.

ROLE DESCRIPTION

Provide support to the implementation of the clinical research operations programme for all appropriate therapeutic areas in accordance with all applicable regulations for Medical Devices. Plan & implement a programme of monitoring for all international regulatory and post marketing clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.

RESPONSIBILITIES

- Provide support to Clinical Trial Leader and Site Monitor for agreed projects for the defined therapeutic area by in-house monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.

- Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well-being of all trial participants and good/rigorous scientific practice.

- Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees.

- Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.

- Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.

- Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.

- Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team.

- Maintain compliance with Company SOPs.

- Maintain a high standard of housekeeping and filing accuracy.

REQUIREMENTS

- Bachelor in a relevant area
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management for internal guidelines.
- Language proficiencies: English and Dutch spoken and written

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Mitchell Jonk.