Senior Clinical Trial Coordinator

Alira Health; München; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Alira Health is seeking a Senior Clinical Trial Coordinator in München, Germany. This role involves assisting the clinical research team to ensure studies comply with GCP and protocols while managing timelines and budgets.

You will oversee junior coordinators, manage start-up activities, and maintain vendor relationships. Applicants should have a degree in a scientific field and prior clinical research experience. Strong analytical and communication skills are essential for success.

Qualifikationen

• Graduation in scientific/health field.
• Previous experience in clinical research (CROs, Pharma, or academia/hospital).
• Good knowledge of ICH GCP and appropriate regulations.

Aufgaben

• Responsible for start‑up activities, including ethical and regulatory submission.
• Training and support of junior CTCs for use of tools.
• Responsible for vendor management.

Kenntnisse

Clinical Research

Regulatory Requirements

Project Management

Analytical Skills

Communication Skills

Ausbildung

Bachelor of Science (BS): Biology

Bachelor of Science (BS): Medicine

Tools

MS Office Suite

Jobbeschreibung

Senior Clinical Trial Coordinator

Assists the clinical research team to ensure the study is conducted in accordance with GCP, relevant SOPs, and protocol, respecting budget and timelines. Collaborates with the Study Start‑Up team to ensure start‑up activities are performed with quality and on time. Oversees and mentors junior Clinical Trial Coordinators and other team members as needed.

Key Responsibilities

• Responsible (under PM oversight and in conjunction with the Study Start‑Up Team) for start‑up activities, including ethical and regulatory submission at national and international levels and site contract negotiation.
• Responsible for ISF preparation and TMF set up and maintenance (under PM oversight).
• Training and support of junior CTCs for use of tools, e.g. CTMS.
• Maintains relationship with ECs and CA for e.g device, observational, real‑world evidence studies.
• Supports in sites/vendors invoicing management and maintains appropriate tracking if required.
• Responsible for vendor management (under PM oversight).
• Collaborates on the preparation of weekly/monthly and ad‑hoc project reports, updates CTMS and maintains study‑specific trackers as needed.
• Supports CRA activities follow‑up.
• Supports document translation, if required.
• Participates in internal, client/sponsor, scientific, and other meetings as requested, and participates in audits.
• Performs additional duties as assigned.

Desired Qualifications & Experience

• Graduation in scientific/health field.
• Previous experience in clinical research (CROs, Pharma, or academia/hospital).
• Good knowledge of ICH GCP and appropriate regulations.
• Good knowledge of Clinical Research and Regulatory/Ethical requirements.

Technical Competences & Soft Skills

• English, good.
• MS Office Suite, good.
• Professional.
• Trustworthy.
• Quality focused; careful, thorough, and detail‑oriented.
• Strong organizational skills and ability to multi‑task and work effectively in a fast‑paced environment; able to manage priorities and organize time.
• Strong analytical skills.
• Strong communication and interpersonal skills with customer service orientation.

Working Conditions / Physical Demands

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.

Languages

English

Education

Bachelor of Science (BS): Biology; Bachelor of Science (BS): Medicine

Contract Type

Regular