Clinical Trial Assistant*

AiCuris Anti-Infective Cures AG; Wuppertal; Vor Ort; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Clinical Trial Assistant, um das Team bei der effizienten Verwaltung klinischer Studien zu unterstützen. Diese Rolle umfasst die Unterstützung des Trial Managers, die Pflege von Dokumenten und die Zusammenarbeit mit internen und externen Partnern. In einem dynamischen Umfeld haben Sie die Möglichkeit, Ihre organisatorischen und kommunikativen Fähigkeiten einzubringen und sich in einem Team von Experten weiterzuentwickeln. Mit einem Fokus auf wissenschaftliche Exzellenz und einem unterstützenden Arbeitsumfeld bietet diese Position die Chance, einen bedeutenden Beitrag zur Verbesserung der Patientenversorgung zu leisten.

Leistungen

Flexible Arbeitszeiten

Entwicklungsmöglichkeiten

Kollaboratives Arbeitsumfeld

Qualifikationen

• Abschluss in Pflege oder Lebenswissenschaften oder gleichwertige Berufserfahrung.
• Fähigkeit, genaue und organisierte Studiendokumentation aufrechtzuerhalten.

Aufgaben

• Unterstützung der Trial-Management-Aktivitäten und Dokumentenmanagement.
• Pflege des Trial Master File (TMF) gemäß ICHGCP und SOPs.

Kenntnisse

Organisatorische Fähigkeiten

Teamarbeit

Kommunikationsfähigkeiten

Detailorientierung

Deutsch (fließend)

Englisch (fließend)

Anpassungsfähigkeit

Ausbildung

Abschluss in Pflege oder Lebenswissenschaften

Ähnliche Berufserfahrung in der Pharma-/Biotech-Branche

Tools

MS Office

CTMS

Jobbeschreibung

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 ICHGCP and to the required regulatory standards especially with document management tracking and archiving.

Responsibilities

1. 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.
2. Liaises with key members of the trial and project team both internal and external including Vendors (e.g. Laboratories) and CRO staff.
3. Participate in clinical study team meetings both internal and external.
4. Setup and maintenance of the AiCuris paper Trial Master File (eTMF) and / or CROs electronic Trial Master File (eTMF) according to ICHGCP and SOPs under supervision of the Clinical Trial Manager.
5. Perform trial-specific in-house filing and archiving and assisting Clinical Trial Manager with ongoing and final QC checks of TMFs (paper and electronic).
6. 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).
7. Other duties as assigned (e.g. Deputy Archive Responsible).

Your profile

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

Why us

1. 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.
2. Development: We encourage people to grow and strongly support individual development and learning opportunities.
3. Flexibility: Embracing flexible working accommodations we enable our people to integrate business into their personal life.

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.