Clinical Trial Assistant

at  AiCuris GmbH Co KG

YOUR MISSION

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 Anti-infective Cures AG is a leading clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients. Our front-runner drug Prevymis®, a prophylactic treatment for CMV infection in transplant patients, is marketed globally since 2017 by MSD (Merck & Co.). Prevymis® is followed by an innovative pipeline of antiviral agents including our wholly owned therapeutic candidate Pritelivir, which is currently in phase III pivotal clinical development.

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.

• 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