Committed to making the difference
AiCuris – founded in 2006 – is a specialist for infectious diseases. Its focus comprises discovery, research and development of novel antiviral and antibacterial agents in the indications human cytomegalovirus, herpes simplex virus, hepatitis B virus, adenovirus, and (multi-)resistant bacterial infections treated in the hospital. With its highly innovative pipeline, AiCuris addresses specialist markets and severe, potentially life-threatening infections with high medical need. Major steps for the company were signing a license agreement with Merck & Co. (MSD) and the marketing authorization for Prevymis™ (Letermovir) in the US and Europe.
To support our development team we are looking for a
Clinical Trial Manager (m/f/d)
The role is to manage, coordinate and supervise all processes regarding clinical trials (Phase 1–3) in collaboration with the AiCuris project team, medical experts, service providers (CROs/ CMOs), and ethical / regulatory bodies. As experienced Clinical Trial Manager, you will take over the responsibility for the proper and high-quality execution of our clinical trial management from planning to execution and the monitoring of all processes related to the trial.
- Manage, implement, coordinate, and supervise all processes needed for clinical trial start-up, trial conduct and trial close-out from sponsor’s perspective
- Support trial centre and patient recruitment, take care of the cooperation with the trial centres, being their central sponsor contact person throughout the entire project
- Contract management with trial centres and CROs as well as other external service providers
- Supervise CRO’s and other external service providers’ performance with respect to implemented processes, quality, timelines, milestones and costs
- Track and supervise trial budget and data quality
- Prepare data, be responsible for the trail documentation and support the creation of presentations, trial documents and publications
- Organise, support and accompany audits at trial centres and external service providers
- Work closely with internal functions such as medical affairs, regulatory affairs, pharmacovigilance, pharmacokinetics and external service providers (e.g. data management, statistics, monitoring, central laboratories)
- Identification and optimisation of processes to increase quality and effectiveness; work on the further development of the departmental internal SOP system by writing and reviewing SOPs
- Scientific or medical background (university degree or experience in a medical profession, e.g. as a nurse)
- Advanced knowledge in pharmaceutical business (5+ years)
- 3+ years of experience in planning and conducting international clinical trials, preferably as Clinical Trial Manager, Project Manager or in a comparable position
- Familiar with applicable local and international law and guidelines (e.g. ICH-GCP)
- Familiar with EDC systems
- Good organisational and communication skills, team player, capable of setting priorities and to manage high workload, used to working in a proactive manner
- Positive and constructive attitude, people management competencies and trustworthiness
- Business-fluent in English; German skills would be beneficial
You can download the PDF of the job description here.
What we can offer
We offer an exciting and challenging job in an innovative company with a promising R&D portfolio and a highly motivated team exhibiting many years of Big Pharma and Biotech R&D experience.
How to apply
Interested to join our team? Then apply online (click here). If you have any questions, please do not hesitate to contact us at +49 202 317 63 2599.
AiCuris Anti-infective Cures GmbH
Tel.: +49 202 317 63 2599