The Clinical Data Manager is responsible for designing, building, validating, and processing clinical study data in a GCP/ISO14155-environment with a focus on medical devices and in-vitro diagnostic devices (IVDs) at Qserve’s Contract Research Organization (CRO). The Clinical Data Manager ensures the quality of the data and designs and builds clinical databases based on study protocols.
Write and/or review plans/study protocols, reports, and supplemental documentation for clinical documentation;
Implementation, monitoring, and supervision of data management activities within assigned clinical trials, i.e. responsible to design, create, validate, reviewing, approving, and maintaining data management tool specifications, including but not limited to: Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans, and Data Management Plans (DMPs);
Provide the study status updates with respect to data, using standard reports (data entry, queries, SDV, safety reconciliation, etc.) and communicate efficiently the status to the team;
Creation and execution of data quality checks throughout study conduct;
Day to day responsibilities (under the guidance of senior personnel) may include but are not limited to: data review, open/close queries in the eCRF, medical coding, central lab data reconciliation, add-hoc data reports creation, User Acceptance Testing (UAT) of internal and external electronic Data Capture systems;
Provides support to the resolution of issues and inputting ideas to help resolve issues and contribute to continuous improvement;
Coding of diagnoses and side effects, the design of Case Report Forms;
Evaluate results of data with the Clinical Project Manager (CPM) who is the liaison to the medical device manufacturers (sponsor) and who ensures the development of the necessary study documents, secures ethics approval and competent authority approval, and manages the study results from start-up to close-out;
More in general, and in consultation with colleagues as CPM’s, CRA’s and Head of CRO, the Data Manager contributes to the further development of the CRO;
Provide advice on relevant business processes, write, correct or review relevant policies, procedures or templates;
Ensure customer satisfaction, adherence to Qserve, and customer policies and procedures in the conduct of work.
The Clinical Project Manager (CPM) is responsible for the planning, setup, and execution of clinical investigations for medical devices and in-vitro diagnostic devices at Qserve’s Contract Research Organization (CRO). In close cooperation with the sponsors (medical device manufacturers), the CPM ensures the development of the necessary study documents, secures ethics approval and competent authority approval, and manages the study from the start to the end. The CPM works closely together with other CPM’s and leads small diverse teams of in-house and contract Clinical Research Associates (CRA’s) and other team members.
The CPM is responsible for the budget, planning, and deliverables of the project and ensures deadlines are met. Besides that, the CPM provides operational support, for example by conducting (co-)monitoring visits and providing trainings. Most studies take place in Europe but some of them might be in the US, China, or other regions. The CPM role is a wide and diverse responsibility.
Besides the day-to-day operational responsibility, you participate in strategic clinical projects including the writing of study protocols, post-market clinical follow-up plans, and clinical evaluation reports.
What you’ll bring to the team
Technical or scientific degree (MSc or PhD) in a health-related field (biology, medical, biomedical engineering or similar) or a degree in mathematics, (bio) statistics, data science & other applied sciences;
Minimum of 2 years experience as Clinical Data Manager, or similar function with relevant experience;
Experience with medical devices and in-vitro diagnostic devices is highly preferred as well as good working knowledge of the ISO14155 standard and ICH-GC;
Experience with electronical data systems and MS Office;
Experience with clinical data studies and reviewing study data documentation is required;
Fluent in English (written and spoken) and preferably one or more other languages;
Ability to work in small teams with high individual exposure and responsibility;
Efficient, accurate, independent, pro-active team-player with good communication skills.
Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!