Clinical Trial Manager (m/f/d)

Gulp Ag; Holzkirchen; Remote; EUR 90,000 - 130,000; Full time

Job summary

Gulp AG is seeking a dedicated Clinical Trial Manager / Clinical Operations Manager (m/f/d) for a 100% remote position. You will plan, manage, and oversee national and international clinical trials from feasibility to study completion, collaborating with the COAD and external vendors.

Required qualifications include Life Sciences education, clinical development experience, and strong knowledge of ICH/GCP guidelines.

Qualifications

• Bachelor or Master in Life Sciences or equivalent healthcare qualification.
• Experience in clinical development within the pharmaceutical industry.
• Prior Clinical Operations exposure is desirable.
• Solid knowledge of ICH/GCP guidelines and international regulatory requirements.
• Proven ability in risk management and TMF care.
• Fluent German and English written and spoken.

Responsibilities

• Plan, manage, and oversee national and international clinical trials.
• Coordinate with COAD and manage external CROs to ensure timely results.
• Create and review trial documents (protocols, ICFs, manuals, safety plans).
• Implement sponsor oversight plans and conduct oversight visits.
• Identify deviations, manage risk, and ensure TMF readiness.
• Monitor study budgets, invoices, accruals, and IMP tracking.

Skills

Analytical skills

Negotiation

Assertiveness

Solution-oriented

German (fluent)

English (fluent)

Education

Bachelor/Master in Life Sciences

Job description

We are currently seeking a dedicated Clinical Trial Manager / Clinical Operations Manager (m/f/d) for our renowned pharmaceutical client. In this 100% remote position, you will plan, manage, and oversee national and international clinical trials from feasibility studies to study completion. The position is initially offered through a temporary staffing agency until February 28, 2027, with the possibility of extension. We look forward to receiving your application! Operational Study Management: Independent planning, execution, and management of clinical trial activities in coordination with the COAD. Vendor & CRO Management: Management of external service providers (ESPs) to ensure timely and high-quality results. Study Documentation: Creation and review of key documents (e.g., study protocols, ICFs, manuals, safety and project plans). Sponsor & Monitoring Oversight: Implementation of GCP sponsor oversight plans and conducting oversight visits to trial sites. Quality & Risk Management: Identification, handling, and documentation of deviations in collaboration with CQA; conducting risk assessments. TMF Maintenance & Inspection Readiness: Quality control of the Trial Master File (TMF) to ensure ongoing audit and inspection readiness. Budget & IMP Tracking: Monitoring of the study budget (invoices, accruals) and support of IMP management (investigational medicinal products). Employment: 100% remote.

• Education: Successfully completed studies (Bachelor/Master) in Life Sciences (Biology, Pharmacy, Biochemistry) or a comparable qualification in the healthcare sector.

• Professional experience: Experience in clinical development in the pharmaceutical industry.

• Clinical Operations: Relevant prior experience directly in the field of Clinical Operations is desirable.

• GCP expertise: Sound and demonstrable knowledge of the ICH/GCP guidelines and the relevant international regulatory requirements for clinical trials.

• Process experience: Proven practice in risk management and TMF care .

• Soft skills: Strong analytical skills, a solution-oriented approach to work, assertiveness and negotiation skills.

• Language skills: Fluent German and English skills, both spoken and written.