Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial delivers unparalleled outcomes for innovators. Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden. Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights.

Meditrial offers highest level expertise across multiple therapeutic areas. We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards. Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

Clinical Project Manager:
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 escalate 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