The company Based on innovative scientific development, they offer a promising solution to cure patients suffering from severe chronic autoimmune diseases for which there is no adequate therapeutic alternative. The product is currently evaluated in a phase I clinical trial, to rapidly move into phase II of the development. Other therapeutic applications and thus clinical trials are planned for a near future.
You are looking for a professional challenge that allows you to work in a start-up environment in order to lead Clinical Projects ?
Working in a in Clinical Trial Activities is a great opportunity for you and you want to bring your expertise in managing projects and external stakeholders within an international context?
Plus One can offer you this great challenge:
The Clinical Project Manager autonomously manages multiple aspects of ongoing or future clinical studies.
Participates to the definition of the clinical operational plans and manage their successful and timely execution for assigned trials.
Responsible for the selection and management of vendors, including defining their responsibilities, negotiating the contract in accordance with the related budget
From clinical study set-up till study archival, ensure that clinical trials achieve on all related objectives and milestones while delivering within established timelines, budget and quality standards, including adherence to ICH, GCP, and all applicable guidelines and regulations
Manages the clinical study team meetings and coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.
Contributes to Synopsis and protocols development in close collaboration with the VP Clinical and Regulatory
Participates in the development of eCRF
Participates in study data review and other review activities as assigned in accordance with GCP.
Manage the related IMP, clinical trial supplies and biospecimen logistic activities
Performs sponsor oversight activities in accordance with GCP throughout the whole study duration
Proactively anticipates and understands concerns/issues/delays in the project and develops risk assessment and contingency plans. Holds each functional area responsible for associated risk mitigation and management.
Master’s Degree in life science or related field (or equivalent experience)
Minimum of 3 years of clinical research experience - early phases is a plus
You have experience Project Management, Clinical Research early phases (minimum of 3 years), outsourcing management
Solid vendor management skills including significant previous experience negotiating vendor/site contracts and managing the budgets
Flexibility and adaptability in a fast and constant evolving structure.
Proficiency in clinical project management skills. Global project management experience is preferred.
Proven problem-solving skills and operations oriented.
Ability to work autonomously and to make daily operational decisions.
Ability to effectively interface with medical personnel at clinical site(s)
Previous experience in collaborating with KOL is a plus.
Ability to write and edit technical documents, such as synopsis, protocols and other trial-related documents.
Team-oriented with excellent interpersonal skills and willingness to support the development of junior profiles
Fluent in French and English (oral and written communication).
This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Our client offers a permanent position in an innovating and dynamic company located near Liège.They offer also the opportunity to integrate a company for which your impact and your expertise count.
They also offer an attractive salary package in line with the position responsibilities and your experience.
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