Clinical Project Manager

Meditrial; Berlin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Meditrial GmbH in Berlin seeks a seasoned Clinical Program Lead to direct life sciences trials from protocol development to study reports. You will drive timelines, coordinate cross-functional teams, and ensure regulatory compliance and data quality across projects.

The role requires deep GCP knowledge, experience with medical devices, and fluency in English and German. Office-based position with travel availability. Strong budget and sponsor liaison skills are valued.

Qualifications

• 6+ years of experience executing clinical programs in medical devices, clinical trials, data management, or clinical monitoring.
• Bachelor’s in Lifescience; a Master’s in a health-related field is a plus.
• Fluent in English and German.

Responsibilities

• Define and drive study timelines and milestones.
• Coordinate development of project specifications with clinical and regulatory teams and ensure quality control of deliverables.
• Contribute to regulatory documents and responses to Health Authorities, EC/IRB, and DSMB questions.
• Plan, organize, and lead Investigator meetings and CRA training; review related material.
• Oversee monitoring activities and conduct co-monitoring visits to ensure data quality.
• Provide study-specific direction to study team members and manage enrolment/retention issues.
• Ensure proper study documentation is maintained and archived in the TMF; escalate risks as needed.
• Provide regular study status updates to the CMO and Sponsor TCs.
• Create, manage and track study budget including revisions and final reconciliation at trial closeout.

Skills

Clinical trial management

Data Management

Clinical Monitoring

GCP knowledge

Regulatory knowledge

Education

Bachelor’s degree Lifescience

Master in a health-related field

Job description

Industry: Lifesciences Industry: Pharma, Medtech, Digital Health

Employment Type: Full-time

Job Functions: Clinical Affairs

Location: Meditrial GmbH, Kantstrasse 21, 10623, Berlin

Workplace: In Office

Travel Available to travel on short notice

The role will contribute to providing direction to the Clinical Team to ensure all trial outputs (from protocol development to Clinical Study Report) are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines. The role will be responsible for project delivery of clinical studies to meet contractual requirements focusing on productivity and sponsor satisfaction. The position will be ultimately accountable for the management of their own study leveraging his/her expertise to drive excellence and strategic support to clients.

Responsibilities

• Define and drive study timelines and milestones
• Coordinate the development of project specifications in collaboration with clinical and regulatory teams and ensure appropriate quality control of deliverables
• Contribute to the development of regulatory documents, responses to Health Authorities, EC/IRB and DSMB questions
• Plan, organize and lead Investigator meetings and CRA training & review related material
• Oversee monitoring activities and conduct co-monitoring visits (if applicable) to ensure data quality
• Provide study-specific direction to study team members
• Address enrolment and retention issues, identify and implement actions to keep the study on track
• Ensure proper study documentation is maintained and archived in the TMF
• Resolve issues in a proactive and timely fashion and elevate unresolved issues and identified risks to identified roles in the company as appropriate
• Provide regular study status updates to the CMO and during Sponsor TCs
• Create, manage and ensure tracking of study budget including revisions and perform final reconciliation at trial closeout

Qualifications & Personal Skills

• 6+ year experience executing clinical programs in medical devices clinical trials, Data Management or Clinical Monitoring
• Education: Bachelor’s degree in Lifescience, Master in a health-related field is a plus
• Languages: fluent English and German
• Previous experience in a pharmaceutical, CRO or medical device company required
• Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485