Clinical Trial Manager (h/f)

5 jours restants

Recruteur
Unique Wavre
Région
MONT-SAINT-GUIBERT
Publication
vendredi 29 mars 2019
Date limite
lundi 29 avril 2019
Réf
1605C6UNQ-BE
Contact
Unique Wavre Office
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein

Our client is active in the bio medical and bio technology sector



Job Description

As a Clinical Trial Manager, the job purpose is to drive all assigned clinical operations’ activities related to the clinical studies from protocol summary, study site selection and regulatory activation process to Clinical Study Report

• Select and activate chosen study sites, establish and maintain an excellent relationship with site investigators and research teams

• Create and update activities in overall project plan on a regular basis to assure appropriate outcome of clinical trial projects in terms of scope, timelines and objectives.

• Supervision of assigned CRA monitoring activities

• Ensure study quality/GCP compliance to deliver a rigorous patient data

• Partner with Lead CTM and provide oversight to all vendors or study delivery team, ensuring timely delivery of milestones and within budget

• Propose and implement study process improvements; Participate in the preparation, updating and training of SOPs

• Liaise with manufacturing, central lab, and other study project stakeholders as needed

• Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans)

• Works with the Lead CTM to develop and maintain study timelines

• Responsible for ensuring vendors deliver according to scope of work and review/approve vendor invoices



Job Requirements

As a Clinical Trial Manager you have :

• A Degree in Life Science, biological science, or related area: B.S or equivalent relevant experience

• Minimum 5 years’ experience in Clinical development in Biopharma industry (sponsor and/or CRO)

• 2-4 years’ experience in project management in early phase oncology, prior small start-up company experience in biotechnology highly desirable

• Strong knowledge of ICH and GCP rules and of the complete clinical trials process

• Creative and finding ways to get the job done. Thriving in challenging environments and finds ways to remove obstacles to complete enrollment and deliver a robust patient data package

• Flexible mindset capable to manage change and deal with ambiguity.

• Proven ability to manage complex projects. Flexibility to re-prioritize workload to meet changing timelines, adaptability.

• Excellent communicator able to raise the profile of clinical studies within sites and create advocates for recruitment.

• Autonomous, pro-active personality. Driven to achieving highest results in shortest timeframe.

• Efficient in planning and executing work: orchestrate multiple activities at once.

• Team player, able to manage matrix organization in multi-cultural environment.



Salary and Benefits

Our client offers you an attractive salary package:

- A salary based on your skills and experience

- Meal vouchers

- Insurances

- Bonus

- Car and fuel card