Meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access. Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators. Our successful track record supporting medical device and biotechnology companies 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. Meditrial, as a recognized leader in the medtech field participates in the development of global standards, policies and regulations. We have the ability to transcend the current landscape with "smart" technology enabled data collection tools and insights that are being regulated by the medical device "rule book". With over a decade of history, operating throughout Europe to manage trials sponsored by global companies, we offer highest level expertise across multiple therapeutic areas including notable depth in cardiovascular and respiratory, orthopedics, oncology, CNS, infectious disease, endocrinology, diabetes, among other indications. We are passionate about our mission to support the innovation and development of better therapies in healthcare 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 Data Manager:

We're looking for a skilled and detail-oriented Clinical Data Manager to join our medical device trials team. You'll own the full data management lifecycle across Phase I-IV studies, ensuring data integrity, regulatory compliance, and on-time delivery. This is a high-impact role for someone who thrives in a fast-paced, multi-project environment and takes pride in clean, audit-ready data. The position is office based in our US Minneapolis Office. Responsibilities Lead end-to-end clinical data management activities for medical device studies across multiple therapeutic areas and all trial phases (I-IV) Design, build, and validate eCRFs and clinical databases using industry-standard EDC platforms (Medidata Rave, Oracle InForm, Veeva Vault, or similar) Develop and maintain key data management documents including DMPs, DVPs, edit check specifications, and data transfer agreements Perform ongoing data review, query management, and SAE reconciliation to ensure timely, high-quality data Collaborate with biostatistics, clinical operations, regulatory affairs, and medical monitors throughout the trial lifecycle Ensure all data management activities comply with

FDA 21 CFR

Part 11, ISO 14155, ICH E6(R2) GCP, MDR and applicable regulatory frameworks Support internal and sponsor audits; maintain inspection-ready TMF documentation Contribute to process improvement initiatives and SOP development Qualifications & Personal Skills 5 years of clinical data management experience, with at least 2 years in medical devices Hands-on proficiency with one or more

EDC/CDMS

platforms (Medidata Rave, Oracle InForm, Veeva Vault, or equivalent) Solid working knowledge of

FDA 21 CFR

Part 11, ISO 14155, and

ICH GCP E6

(R2) Experience managing data across multiple concurrent studies and therapeutic areas Strong understanding of CDISC standards (CDASH, SDTM) is a plus Exceptional attention to detail and a systematic approach to problem-solving Excellent written and verbal communication skills; comfortable interfacing with sponsors and cross-functional teams Bachelor's degree in a life sciences, health informatics, or related field (Master's a plus)