Clinical Trial Assistant*

AiCuris GmbH; Duisburg; Vor Ort; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Trial Assistant to support the Clinical Trial Manager and team in managing trials efficiently. This role involves document management, tracking, and archiving, ensuring compliance with ICH-GCP and regulatory standards. You will be part of a collaborative environment that values scientific excellence and offers opportunities for personal development. If you thrive in dynamic settings and are passionate about improving patient lives, this position is an exciting opportunity to contribute to meaningful clinical research.

Leistungen

Unique corporate culture

Development opportunities

Flexible working accommodations

Comprehensive benefit plan

Qualifikationen

• Degree in nursing or life sciences or equivalent experience in pharma/biotech.
• Strong organizational and communication skills with attention to detail.

Aufgaben

• Support trial management activities and maintain study status trackers.
• Liaise with trial team members and assist in quality-related initiatives.

Kenntnisse

Organizational Skills

Communication Skills

Teamwork

Attention to Detail

Adaptability

Proficiency in MS Office

Fluent in German and English

Ausbildung

Degree in Nursing

Degree in Life Sciences

Equivalent Work Experience

Tools

Clinical Trial Management Systems (CTMS)

MS Office

Jobbeschreibung

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).

Your profile

• Degree in nursing, life sciences or medical documentation or demonstratable equivalent work experience in the pharmaceutical/biotech industry.
• Ability to maintain accurate and organized study documentation. General understanding of ICH-GCP and relevant EU regulatory guidelines (EU CTR 536/2014).
• Willingness to stay updated on industry trends, regulatory changes, and advancements in clinical operations methodologies.
• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.
• Able to work independently, in a structured and meticulous manner.
• Strong teamwork and organizational skills and reliability.
• Proficiency in using various software tools and applications, including MS Office package.
• Willingness to learn about various software tools and clinical trial management systems (CTMS).
• Strong verbal and strong written communication skills.
• Fluent written and spoken German and English skills.

Why us?

• Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.
• Benefits: Competitive comprehensive benefit plan.