Clinical Data Manager
An exciting global immunology company developing antibody-based medicines are looking for a talented for Clinical Data Manager to join their team in Ghent. This organisation is adamant on translating immunology breakthroughs into first class antibodies.
- Take a leadership role with the CRO, clinical study team and other internal and external partners to establish, align and conform data management expectations for the assigned trials.
- Set quality expectations and timelines for data management deliverables and will regularly follow up on data management milestones
- Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.
- Participate in CRO selection and contract negotiations together with the argenx clinical study team and the Vendor Management representative
- Contribute to development of the protocol for the sections relevant for DM (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions
- Oversee all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan,
- Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.
- Participate in User Acceptance Testing Activities for the applicable Data Collection Tools
- Perform adequate Quality Control for data completeness and accuracy
- Contribute to the development in lessons learned and shares best practices within the trial and department.
- Lead/participate in initiatives on process improvements
- Participate in regulatory inspections and company audits
Skills and Requirements
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
- Strong communication and interpersonal skills
- Fluent in English
- Bachelor's degree or Master's degree - medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience
- Demonstrated experience in Clinical Data Management
- Experience in managing CROs and vendors is a plus
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Magenis at 0203 854 1050 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.