Clinical Operations Manager - Mont-Saint-Guibert, België - Novadip Biosciences

Novadip Biosciences

Geverifieerd bedrijf

Mont-Saint-Guibert, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Responsibilities:

Organization and management of clinical operations activities, adhering to standards and regulations required within the field: notably ICH guidelines (including GCP) and all other EU/US legislation and directives relating to clinical research activities.
Development, management and evaluation of all aspects about "Clinical Compliance" in partnership with the Clinical Quality representative
In partnership with the Clinical Director and Clinical Science Manager:
Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, INDs, IMPDs, study synopses and protocols, clinical study reports, DSURS and other safety reports.
Provide input into clinical trial timeless of the clinical development plan.
Execute clinical trials from protocol design to the final clinical study report.
Streamline financial management to ensure proper forecasting, budgeting and oversight for the implementation of the clinical development plan.
Provide expert clinical operations input into preparation for essential regulatory meetings (e.g., Pre-IND, EndofPhase 2, Scientific Advice Meetings)
Line management of the clinical operations team
Provide as needed handson support to the clinical operations team in the:
Preparation and/or management of all documentation relating to a clinical trial (e.g., study protocol, patient informed consent, CRF, trial management plan, risk management plan, safety plan)
Selection and management of CRO and other subcontractors involved in the clinical trials.
Management of interactions with ethics committees and competent authorities
Monitoring and coordination of patient recruitment plans
Coordination of exchanges with investigators and management of site visits
Training/ coaching operational teams involved in clinical trials (interna and external)
Conduct of onsite monitoring, trial logistics, and establishing permanent contact with named investigators.

Profile:

Scientific educational background: Master or PhD.
Minimum 10 years of experience in clinical research experience with a pharmaceutical company or CRO (preferably including people management) with a handsonmentality.
Management experience with multicenter studies including global clinical trials (US study conduct is an asset).
Strong understanding of the principles of clinical trial conduct and project management.
Solid experience in CRO management.
Strong regulatory knowledge, including Good Clinical Practices (GCPs).
Experience with protocol, ICF, CRF and CSR development and review.
Strong organizational skills and ability to deal with competing priorities.
Excellent leadership skills.
Solid computer skills with a working knowledge of Windows and Microsoft Office.
Good oral and written communication skills, be able to communicate effectively in English.

Offer:

A fulltime permanent position (40h/week) within a highpotential innovative biotech company.
To work in a humansized, dynamic, respectful, and professional environment.
The opportunity to take part in a challenging scientific and business growth.
An attractive salary package in line with the position responsibilities and your experience.