For the expansion of our client's clinical team, we are looking for a Clinical Data Manager (CDM).
The company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Their unique antibody engineering technologies combined with the complementary expertise of their people enables them to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
The CDM is responsible for all clinical data management aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:
- Responsible for leading, guiding and overseeing the CROs data management activities and responsible for overseeing vendors involved in the assigned clinical studies based upon metrics and plan
- Assisting in CRO contract negotiations together with the company’s clinical study manager and Director Vendor Management
- Providing input into and/or developing study related materials such as Clinical Study Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF/EDC and Edit Check Specifications, eCRF completion guidelines, External Data Reconciliation Plans, SAS Listing Specifications, Lab Data Transfer Plans, etc.
- Overseeing and tracking patient data entry and query resolution following agreed timelines
- Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations related to Data Management activities
- Reviewing protocol deviations and related data listings for studies to ensure that high quality data are delivered and identifies and solves structural issues/concerns
- Performing QA/QC checks of the data recorded in the clinical database in line with the company’s quality standards
- Ensuring timely collection of CRF documentation for periodic Medical Review and IDMC/DSMB Review
- Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to the Clinical Study Manager, Project Manager, Head of Clinical Operations or Senior Management, if needed
- Assisting the Clinical Study Manager in the preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan and quality in line with the company’s quality standards for Data Management related activities
- Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
The CDM will also participate in activities other than study-related which included but are not limited to:
- Co-writing/maintaining SOPs within the Clinical Operations department related to Data Management
- Staying up to date with applicable industry standards related to Data Management (ie CDISC, SDTM, …)
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
- Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF databases, CDISC and SDTM)
- Bachelor’s degree or University degree – medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience
- Minimum of 5 years of experience in Clinical Data Management
- Experience in managing CROs and vendors is a plus
- Biotech experience is a plus
- Auto-immune and/or oncology clinical study background is a plus
- Belgian residence required, since this vacancy is office based
- An attractive salary in line with your experience and skills.
- Fringe benefits including medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.