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Clinical Study Manager (H/F/X)

December 27th 2021

PROMETHERA® THERAPEUTICS is a global innovator in liver therapeutics whose mission is to bring life-saving treatments to reduce the need for liver transplantation. Our lead clinical program, derived from our patented cell technology platform HepaStem™, is designed to benefit from its immune-modulatory and anti-fibrotic properties.

Mission Description

YOUR RESPONSIBILITIES: 
Responsible Person for coordinating all operational aspects of a clinical trial.
Collaborate with other departments in the overall study management of a clinical trial.
Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents. 
Assist in identification and hiring of appropriate CROs and third-party study vendors.
Negotiate and manage the budget and payments for investigative sites, CROs and other third-party vendors.
Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate as appropriate.
Assist with CRA and third-party vendor training on protocols and practices.
Identify, select, and monitor performance of investigational sites for clinical studies.
Develop and maintain good working relationships with investigators and study staff.
Ensure studies are carried out according to the study protocol, SOPs, and ICH-GCP regulations and study specific manuals and procedures. 
Plan, organize and lead internal and external meetings and conference calls.
Track and report on progress of study including site activation, patient enrollment, monitoring visits.
Prepare and review key study quality metrics (e.g., eligibility, primary endpoint data, etc.), provide reports as required to upper management and determine appropriate action in conjunction with study team (autonomy may vary with experience).
Oversee the global study budget of a clinical trial.
Perform clinical data review of data listings and summary tables, including query generation.
Can be home or office based.

Candidate profile

YOUR QUALIFICATIONS / SKILLS: 
Multilingual - Fluency in English required.
Bachelor’s Degree in Life sciences.
At least 4 years’ experience in clinical research.
Good understanding of clinical trials and current knowledge of ICH-GCP.
Detail oriented and strong organizational and interpersonal skills.
Demonstration of flexibility and professionalism.
Good computer skills.
Excellent communicator and a real team player.
Full driving license and willingness to travel on regular intervals nationally and internationally.

Offer

For more information please contact to hr@promethera.com.

Contact Details

If you want to join our team, you may apply for this position by sending your CV and application to hr@promethera.com.