Promethera Biosciences 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. In addition to our cell-based pipeline, we develop antibody technologies, such as the anti-TNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.
If you are sharing our vision of becoming the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 140 people, consider a collaboration with our fast-growing company. Promethera Biosciences is currently hiring a Senior Clinical Study Manager (Senior CSM).
- Responsible Person for coordinating all operational aspects of a clinical trial.
- Collaborates with Medical and Clinical Affairs department and with all 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 to Director or CRO as appropriate
- Assist with CRA and third-party vendor training on protocols and practices
- Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work
- Identify, select, and monitor performance of investigational sites for clinical studies
- Develop and maintain good working relationships with investigators and study staff
- Prepare accurate and timely visit reports from all site interaction visits
- 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
- 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
- Investigate queries, monitor discrepancies
- Perform clinical data review of data listings and summary tables, including query generation Performs other duties as assigned by management;
Additionally, the Senior CSM :
- Is able to manage multiple projects simultaneously with strong organizational and planning skills,
- Can be responsible of bigger projects
- Supervision and Training of CRAs/CTAs/CSM allocated to the studies.
- Proactively identify issues and escalate to appropriate managers in the others department.
- Scientific Background (minimum Bachelor’s degree)
- At least 4 years’ experience as Clinical Study Manager.
- ICH-GCP training
- Good skills in Microsoft Office (Word, Excel, Power Point, Outlook) and experience in EDC systems.
- Fluency in English
- At our headquarters in Mont-Saint-Guibert / Gosselies, Belgium
You may apply for this position by sending your CV and application letter to email@example.com
Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.