Global Clinical Trial Manager

Basel-Stadt  ‐ Vor Ort
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Beschreibung

We are recruiting for a Global Clinical Trial Manager who will be responsible for the execution and management of clinical trials within Translational Medicine. This is on a minimum 18 month contract basis. Your functions would involve the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting, budget, operational and study close out.

Please note that this is an operational position within early phase clinical trials with some elements of scientific know-how. Please read the requirements carefully.

Responsibilities:
  • You will lead and matrix manage a multidisciplinary and global Clinical Trial Team.
  • Responsible for the study set up, maintenance and close out.
  • You will author/manage clinical study protocol by translating the Clinical Development Plan strategy into scientific, operational and executive clinical plan.
  • Collaboration with and management of country affiliates and third party providers.
  • Responsible for budget planning and management, and timely execution of assigned clinical deliverables.
  • You will be responsible for the study set up by identifying sites, selecting external CROs, affiliates and other vendors
  • Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived appropriately.
  • Review and approve all study payments as per financial agreements.
  • Train, support and regularly interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
  • Maintenance of knowledge and training of ICH-GCP, current regulations and procedures.
  • Responsible for the availability of high quality, Translational Medicine data according to agreed timelines and budget to enable no delays in decision making and drug registration.


Requirements
Ideally PhD in Life Sciences, Pharm D. BSc or MSc is also acceptable when paired with robust experience.
  • Relevant experience (5+ years) in clinical trial management
  • Global Project Management skills
  • Experience in study start up, maintenance and close out
  • You will have experience with budget management
  • Experience in early phase clinical studies
  • Experience writing protocols and associated documents
  • Drug Development experience preferred
  • Track record of managing global, multiple, complex clinical trials.
  • Great communication skills; capable of clear written and verbal expression of ideas
  • Great team player and ability to constructively contribute to overall goals.
  • Ability to interact with a wide range of people and build strong positive relationships.
  • Potential for customer orientation awareness and focus.


Kontact: or call

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
05/2018
Dauer
04/2019
Von
Michael Bailey Associates
Eingestellt
13.04.2018
Projekt-ID:
1537591
Vertragsart
Freiberuflich
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