Functietitel: Clinical Data Manager

Functieomschrijving:
For one of our partners in the region of Ghent, we are currently looking for a Clinical Data Manager. You’ll execute several Data-Management activities within the framework of clinical trial activities. This all to ensure the completeness, accuracy and consistency of the data so they meet the standards of quality for analysis and reporting to regulatory bodies in compliance with local and global regulations. You’ll be involved in every clinical trial program in order to perform all necessary activities. Protocol development Contribution to synopsis and, or protocol design (feasibility of data collection) Protocol review Trial start up: CRO-oversight plan Create CRO-oversight plan and review all CRO-documents according to this plan Set-up and follow up on trial timelines Trial start up: set up of data collection tools CRF development (eCRF): review of screen design, dynamics and entry fields, completion guidelines, paper CRF (design and completion guidelines) Review other data collection streams as PRO’s, Data transfer agreements with other vendors Trial start up: set up of data review tools Check data validation checks and listings of CRO on completion and correctness Review data safety measures (plan, medical review, …) Set up protocol violation definitions Trial conduct: Oversight of harvesting and review status Follow up on data collection by CRO (timely entry of data, data transfers, …) Follow up on cleaning status (CRF data, PRO’s, protocol violations, IVRS reconciliation, central lab reconciliation, ECG, bioanalysis data reconciliation, images, SAE reconciliation, coding, …) Trial conduct: Perform QC on mapping and review activities Define QC checks on review and SDTM structure (according CRO oversight plan) and validate in accordance with programmer Review QC output and provide comments and findings to CRO Perform QC on final datasets and merges and provide comments to CRO You will report directly to the Senior Clinical Data Manager Company: Pauwels Consulting is a fast-growing technical consultancy firm with a large portfolio of international corporate clients in Engineering, Pharma and IT. We deliver consultancy and turnkey projects to leading companies in Belgium and beyond. At Pauwels Consulting we value your talent and ambitions. That is why we invest heavily in the continuous education, personal coaching and individual development of all our consultants. At Pauwels Consulting, you will find a challenging and inspiring work environment every single day. Are you interested in working for top companies in your industry and do you like to improve your skills and expertise every day? Then we should definitely meet! We look forward to hearing from you via phone (+32 9 324 70 80) or e-mail (jobs (at) pauwelsconsulting.com).

Werkgever Naam: Pauwels Consulting

Werkgever adres: Pauwels Consulting, , 9000 GENT, BELGIE

Vorm van contact: Isabelle Ballegeer

Job korte beschrijving: Natuurkundigen en astronomen

Land: Nederland

Regio: NEDERLAND

Contractduur: Vast

Contract type: Voltijds

Ervaring: Tussen 2 en 5 jaar

Bron van jobaanbieding:
VDAB, Openbare diensten voor arbeidsvoorziening, België

Hoe toe te passen: Bel WERKGEVER