Clinical Trial Coordinator I

Alira Health GmbH; München; Vor Ort; EUR 30.000 - 50.000; Vollzeit

Benefits dieser Stelle

Global travel

Flexible work programs

Professional development

Diverse team environment

Zusammenfassung

Alira Health GmbH in Munich seeks a Clinical Trial Coordinator I to support the clinical research team, assisting PMs, CRA, and Study Start-up teams to ensure studies comply with ICH GCP and applicable laws. You will handle site identification, feasibility, EC/IRB submissions, TMF QC, and sponsor communications.

The role emphasizes organization, attention to detail, English proficiency, and teamwork across international sites; regular alignment with PMs and CRAs is essential.

Qualifikationen

• Graduation in scientific/health field or equivalent experience.
• Strong command of English, both written and verbal.
• Proficient with MS Office Suite.
• Quality focused; careful, thorough, detail-oriented.
• Strong organizational skills and the ability to multi-task and work in a fast-paced environment.
• Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges.
• Strong communication and interpersonal skills with customer service orientation.
• Permanent authorization to work in applicable country(-ies).
• Previous experience preferred or ability to quickly learn ICH GCP principles and appropriate Regulatory/Ethical requirements.

Aufgaben

• Site identification and feasibility, including initial site outreach, NDAs and related activities.
• Support PMs with meetings, agendas, and minutes.
• Site start-up activities including EC/IRB submissions and budget negotiation.
• Maintain relationships with ECs and Competent Authorities.
• TMF setup, maintenance and QC under PM oversight.
• ISF preparation and distribution to sites.
• Manage study site supplies and related materials.
• Review site Essential Documents with CRAs.
• Assist with CTMS updates and study trackers.
• Maintain study team training materials and invoicing management.
• Assist CRAs with follow-up activities.
• Participate in audits and other duties as assigned.

Kenntnisse

Graduation in scientific/health field

Strong English skills

MS Office proficiency

Organizational skills

Analytical skills

Communication skills

Problem-solving

Permanent work authorization

Ausbildung

Bachelor of Science (BS)

Tools

MS Office Suite

Jobbeschreibung

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

THE CLINICAL TRIAL COORDINATOR I ROLE

The Clinical Trial Coordinator (CTC) I assists the clinical research team, supporting Project Managers (PMs), Study Start-up team, Clinical Research Associates (CRAs), and clinical sites to ensure studies are conducted in accordance with ICH GCP, applicable laws, SOPs, and the protocol in respect of study budget and timelines.

ESSENTIAL JOB FUNCTIONS

• Responsible (in collaboration with PM, CRAs, and Study Start-up team, as applicable) for site identification and feasibility, including initial site outreach, follow-up, and circulation and collection of feasibility questionnaires and Non-disclosure Agreements (NDAs)
• Supports PM with the management of and participation in internal, client/sponsor, scientific, and other meetings as required, including but not limited to supporting with scheduling meetings and preparing agendas and meeting minutes
• Responsible (under PM oversight and in collaboration with Study Start-up team, as applicable) for site start-up activities, including Ethics Committees and Institutional Review Boards and Regulatory submissions (at site, national, and international level, as applicable) and site contract and budget negotiation
• Maintains relationships with Ethics Committees (ECs) and Competent Authorities (CAs), as applicable
• Responsible for document management including Trial Master File (TMF) setup maintenance and TMF QC (under PM oversight)
• Supports PM with Investigator Site File (ISF) preparation and distribution to sites
• Supports the PM with the management of study site supplies
• Supports collection and review of site Essential Documents, in collaboration with CRAs
• May support regular communication with sites to address questions, ensure protocol/GCP compliance, determine study progress and monitor subject accrual
• Supports PM with study management activities throughout life cycle of study; collaborates in the preparation of weekly/monthly and/or ad hoc project reports, updating CTMS, and maintaining study-specific trackers as needed
• Supports PM with maintenance of study team training materials
• Supports PM with site/vendor invoicing management, as applicable
• Supports CRAs with follow-up activities
• Supports PM with document translation, as applicable
• Participates in audits, as applicable
• Performs additional duties as assigned

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Graduation in scientific/health field or equivalent experience
• Strong command of English, both written and verbal
• Proficient with MS Office Suite
• Quality focused; ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time
• Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges
• Strong communication and interpersonal skills with customer service orientation
• Professional and trustworthy
• Permanent authorization to work in applicable country(-ies)
• Previous experience preferred or ability to quickly learn ICH GCP principles and appropriate Regulatory/Ethical requirements.

Salary Range Euro 30.000 - 50.000

Languages English

Education Bachelor of Science (BS)

Contract Type Regular

Salary Range The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. EUR 30,000 - 50,000 gross annually

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more.

We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.