- Protocol development: Contribute to protocol design (e.g., what and when data are to be collected, feasibility of data collection), protocol and amendment review
- Be an active member of the clinical trial team
- Trial start-up: set up of data collection tools: create and maintain the data collection tool oversight form, review (e)CRF and ancillary documents related to data collection (e.g., data transfer agreements with other vendors, PRO’s, diaries…)
- Trial start-up: set up of data handling tools: create and maintain the data handling tool oversight form. Check data validation measures for completeness and accuracy, review data safety measures (plan, medical review, SAE reconciliation plan…), contribute to definition of protocol deviations.
- Trial conduct: create and maintain the data management quality plan, oversee CRO’s data collection/review metrics, evaluate SDTM definitions and mapping, perform data content and structure QC and maintain the data management quality report.
- Trial close-out: perform final QC on CRO deliverables, ensure completeness of data package before database lock, finalize all required documentation and oversee transfer and archiving of the data management component of the Trial Master File.
- Follow up on trial timelines from trial start till close out and perform proper issue escalation if required
- Lead/participate in initiatives on process improvements
- Participate in regulatory agency and internal audits, when appropriate
- Accuracy / Precision: needs to be very meticulous
- High quality standards, an eye for details
- Able to work independently but also in a team environment
- Negotiation skills
- Strong communication and interpersonal skills
- Analytical skills
- Fluent in English (written and spoken)
- Expected educational qualifications: Bachelor or Master Degree in relevant field of life sciences or equivalent experience/education
- Expected experience: 1-7 years of previous experience in DM is required