To ensure effective support for our clients in their recruitment process, at Valesta we are continuously searching for experienced
Clinical Project Managers
- Do you hold a Master or Ph.D. in life sciences?
- Do you have at least 3 years Clinical Project Manager experience in an international environment?
- Are you a “leader”, with proved organizational and time management skills?
Then you might be the candidate we are looking for! Read more and apply, we are waiting for you!
As Clinical Project Manager you are primarily accountable for the end to end execution of the assigned protocols, in compliance with ICH/GCP and national regulations, internal policies and procedures and applicable quality standards. You act in a matrix organization structure as coordinator of all activities related to 1 or more clinical trials, including timelines, budget, and quality.
- You are in charge of the operational implementation of the trial protocol
- You have the responsibility of the operational aspects during the planning, start-up, conduct and close-out study phase, including coordination of trial-related activities
- You ensure the quality and the integrity of the data and adherence to the agreed project timelines and budget
- You identify the necessary timelines and resources for each study.
- You take the lead or you will be closely involved in the selection of CRO's and external vendors, you ensure their training and management throughout the study
- You prepare local approval documents and ensure their timely submission according to local processes
- You contribute to the timely development and/or update of trial-specific documentation (e.g., Protocol, ICF, Risk Management Plan, trial-related vendor documents…)
- You are the single point of contact for Clinical Operations-related questions throughout the whole study period
- You act as Clinical Study Representative in clinical working groups
- You provide regular updates on trial evolution to the project teams and management and escalate any significant issues
- You contribute to process improvement activities within Clinical Operations
- You are a master or a Ph.D. in life sciences
- You have at least 3 years Clinical Project Manager experience with international clinical operations in Pharma, Biotech or CRO
- You have excellent knowledge of ICH, European directives and FDA guidelines related to GCP
- You have experience with CRO oversight or vendor management
- You demonstrate leadership
- You have strong communication, organizational and proven time management skills
- You easily adapt to changes and have a pragmatic attitude
- You are fluent in English and French. Dutch is a plus