Company Description
GCRI is dedicated to delivering scientifically robust, regulatory-compliant clinical trials with strong operational governance in wound healing, dermatology, orthopedics, and related therapeutic areas. We design and conduct clinical trials and clinical investigations in accordance with applicable US and European regulatory requirements, GCP, relevant international standards, and applicable national requirements.
Our mission is supported by a highly trained workforce, a strong SOP-driven quality framework, and a commitment to scientific integrity, ethical study conduct, and reliable data generation. Through rigorous methodology, effective collaboration with investigators and sponsors, and robust governance and infrastructure, GCRI aims to advance high-quality clinical research that improves patient outcomes and strengthens industry confidence.
Role Description
The Data Manager is responsible for the operational planning, execution, and oversight of clinical data management activities for GCRI-supported clinical trials. They ensure that clinical data are collected, processed, reviewed, and locked in accordance with regulatory requirements, internal SOPs, and sponsor expectations, supporting high-quality, reliable, and inspection-ready clinical trial data.
This is a part-time role based in Copenhagen, with possibility for 100% remote work.
20-30 hours/month, paid hourly, as staff or consultant.
Over time this can be changed into a full-time position, based on the applicants preference.
You will join an international team, with colleagues from Denmark, UK, USA, Spain and Switzerland.
The applicant should be based in Europe.
Duties and Responsibilities
Qualifications
Education: Bachelor’s degree in life sciences, data sciences, biostatistics, health informatics, or a related discipline required. Advanced degree preferred.
Experience: Demonstrated experience in clinical data management for a minimum of 5 years within a Contract Research Organization or similar regulated clinical research environment is required. Experience supporting multicenter clinical trials, managing and building clinical databases, developing CRFs, and coordinating data management activities across internal teams, sites, and external vendors is expected. Working knowledge of applicable GCP, regulatory, data integrity, and clinical data management requirements is required.
Skills: Strong understanding of clinical data flows, database structures, CRF design and development, and data quality processes. Excellent organisational and analytical skills with high attention to detail. Ability to manage multiple studies and priorities in a regulated environment. Strong written and verbal communication skills and ability to work cross-functionally with Clinical Operations, Quality, Medical, Statistics, and external vendors. Proficiency with Electronic Data Capture (EDC) systems and Smartsheet for clinical data management, including the management and storage of data captured using paper CRFs where an EDC is not used, is required. Strong experience with CRF development and clinical database build processes is also required.
Language: Fluency in English with strong written and verbal communication skills.
Travel: None required.