Your mission
AiCuris are looking for a Clinical Trial Assistant based in Germany. The focus of this role is to assist the Clinical Trial Manager and the Clinical Trial Team to manage trials efficiently according to ICH-GCP and to the required regulatory standards, especially with document management, tracking and archiving.
Responsibilities
- Supports trial management activities including but not limited to taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
- Liaises with key members of the trial and project team, both internal and external, including Vendors (e.g. Laboratories) and CRO staff.
- Participate in clinical study team meetings, both internal and external
- Set-up and maintenance of the AiCuris paper Trial Master File (eTMF) and/or CROs electronic Trial Master File (eTMF) according to ICH-GCP and SOPs under supervision of the Clinical Trial Manager
- Perform trial-specific in-house filing and archiving and assisting Clinical Trial Manager with ongoing and final QC checks of TMFs (paper and electronic)
- Assist and participate in quality related initiatives and activities including SOP and other controlled document preparation and inspection readiness activities (e.g. trial specific Sponsor Oversight activities)
- Other duties as assigned (e.g. Deputy Archive Responsible)
About us
AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.
Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other's personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.
*AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.
