Société

Our client, based in the south of Luxembourg, is a company in the medical field. To strengthen its team, this firm is looking for a Clinical Trial Project Manager.

Mission

Your responsibilities :

knowledge of US (21 CFR 812 and other sections) is an advantage

Maintain in depth knowledge of protocol, therapeutic area, and indication

development of study protocols is desired

Provide cross-functional oversight and deliverables

Develop operational project plans

Manage risk assessment and execution

Perform quality checks on submission documents and site essential documents

Prepare and approve informed consent forms

Review pertinent regulations to develop proactive solutions, in close cooperation with Regulatory Affairs

Ability to coordinate and manage project start-up, project maintenance, and project close-out activities

Track study status and progress according to milestones, identify and anticipate potential issues or challenges, and work closely with team and communicate to line manager to develop appropriate solutions

Provide project management oversight to other clinical / medical team members

Develop Study management tools, including but not limited to communication plan, Clinical Monitoring Plan, and other study-specific documents and management tools

Communicate change in scope to clinical / medical team and line manager

May be responsible for other projects and responsibilities as assigned

Provide input (as applicable) on the Study protocol / Clinical Investigation Plan, on the edit check specifications, on the data analysis plan, on the Analysis and on the final study report

Profil

Your profile and qualifications :

You have a Bachelor’s degree in Life Sciences or related field with a minimum of 5 years of related medical device industry experience (i.

e. project management), OR a Master’s degree in Life Sciences or related field with minimum 3 years related medical device industry experience

You have a first experience with medical devices trials

You are fluent in English. Any other language is an asset.

You have measurable knowledge of Good Clinical Practice for medical device trials in the Europe (ISO 14155), and local regulations.

Knowledge of US (21 CFR 812 and other sections) is an advantage

Excellent written communication skill

You are a motivated, hard-working and autonomous person

You are open-minded and solution-oriented.

Conditions and Advantages :

Immediate start of work

Pleasant working environment

Young and dynamic team

Multicultural environment

The candidates' career path :

Analysis of your application

Pre-interview with RH Lab (by phone)

Interview at RH Lab.

2 interviews with our client

Applications sent directly to RH Lab.'s clients are systematically forwarded to us and result in additional processing time.