International Clinical Trial Manager

Région
Bruxelles (BE)
Publication
vendredi 2 juin 2017
Date limite
lundi 17 juillet 2017
Niveau d'expérience
> 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein

ASIT biotech s.a. (formerly Biotech Tools) is a clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies, based on its ASIT+TM technology platform.

ASIT biotech is looking for an

International Clinical Trial Manager

 

Job Description

 

The International Clinical Trial Manager is:

 

• Managing all activities within Clinical Operations related to 1 or more clinical trial(s) (planning, implementing and managing single and multi-site clinical studies), to collaborate with the trial team members and to coordinate all study-related activities.

 

•  Managing clinical study timelines, budget, data quality and data collection.

 

Responsabilities

 

•  Responsible for the operational aspects during the planning, start-up, conduct and close-out phase of the given trial(s) while ensuring the quality and the integrity of the data (e.g. in line with GCP/ICH guidelines) and adhering to the agreed project timelines and budget.

 

•  First point of contact for Clinical Operations-related questions for the given trial(s).

 

•  Provide regular updates on trial evolution to the teams (Clinical Trial Team) and manager, and escalate any significant issues which may have an  impact on patient safety or conduct of the study, timelines, budget and/or data quality.

 

•  Contribute to timely development and/or review of trial-specific documentation (e.g., Protocol, Protocol amendments, Clinical Trial Responsibility Assignment Form, trial- related vendor documents).

 

•  Ensure the timely selection and qualification of CRO’s and vendors, their training and management throughout the study.

 

•  Organize Kick-off Meetings, Investigators meeting and managing the CRO’s output

 

and responsibilities.

 

•  Operational implementation of trial protocol, including coordination of trial-related activities with both internal (medical, regulatory, …) and external (CRO, central/referral labs) parties.

 

•  Potential line manager of Clinical Trial Lead(s) and Clinical Trial Assistant(s).

 

Skills & expertise:

 

•    At least a Bachelor’s degree - medical or paramedical (e.g. pharmacy, biology, veterinary).

 

•   Minimum of 10 years’ experience in leading international clinical operations

 

(Phase 3 experience is a must, in respiratory diseases an asset).

 

•    Excellent knowledge of ICH, European directives and FDA guidelines related to GCP, experienced with adhering to SOPs and guidelines regarding the conduct of clinical trials

 

•    Experience with the clinical development processes, experience with immunology, allergy and respiratory diseases is an asset.

 

•   Team Player.

 

•   Project Management and organizational skills.

 

•   Good Communication skills.

 

•   Flexible, conflict handling and problem solving skills, sense of innovation.

 

•    Being accountable: exercising judgement/impact of decisions/consequence of error.

 

•    Able to manage multiple and varied tasks and prioritize workload with attention to detail.

 

•   Good knowledge of written and spoken English.

 

•   Knowledge of and experience with basic computer programs; experience with      MS Project is an asset.

 

•   Is willing and capable to go the extra mile if needed.

 

•   I willing to develop a new medicine to meet a problematic unmet medical need.

 

Offer:

 

  • A full time position, permanent contract
  • A remuneration that will be in line with the industry standards + additional benefits.
  • An innovative leading company, which could enable you to explore interesting career opportunities.
  • A multicultural work environment in which competence and quality play an important role