Team Lead Database Delivery & Oversight

仕事内容

Make your mark for patients

To strengthen our Clinical Data & Innovation team, based in our HQ, Belgium we are looking for a talented individual to fill the position of Team Lead Database Delivery & Oversight.

As a Team Lead Database Delivery & Oversight you will have the following responsibilities:

• Lead and manage employees and their development and performance, including recruiting, evaluations, training, mentoring/coaching.
• Pro-actively identify and provide oversight to the operational delivery and implementation of Clinical Metadata Repository system (CMDR) across clinical trials based on their characteristics.
• Based on UCB strategic CMDR implementation decisions and using UCB standard libraries existing in metadata repository lead and provide oversight to create study level deliverables:
• Basic eCRF including forms, form instructions, controlled terminologies edit checks, e-mail alerts etc
• Data transfer specification dataset structures for clinical data collected outside of eCRF (e.g. central laboratory, eCOA etc)
• SDTM datasets and RAW to SDTM mappings
• Coordinate the collaboration with UCB colleagues and CRO Partners to align on timelines to finalize the design, creation and implementation of EDC solutions.
• In collaboration with Study Data Leads provide leadership to the planning for data receipt and data quality oversight throughout the duration of clinical trials assigned to the Database Delivery and Oversight team.
• Lead the execution or execute the process of data loads from various sources into the clinical and operational data repositories including the review and communication of issues. Sources may include:
• Strategic Partners
• Non-strategic vendors/CROs
• Central Labs
• Imaging Vendors
• Other data sources relevant for the conduct of clinical trials

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s Degree
• Experience clinical data management and clinical analytics and/or biostatistics.
• Experience managing a team, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Experience with relational databases, preferably Clinical Data Management and EDC Systems, relational database design and/or SAS Advanced familiarity with reporting tools.
• Working knowledge of medical terminology, government regulations, and Good Clinical Practice.
• Knowledge of regulations and industry guidance documents governing clinical data collection structure, SDTM Controlled Terminology, data quality by design, including risk-based approach.
• Demonstrated experience communicating with all levels of personnel and participating in collaborative work team (locally and globally).

Why you should apply

At UCB, we welcome passionate individuals who thrive on change and are ready make their mark for patients. Working for us, you will discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact while putting continuous efforts into cultivating a workplace culture where everyone feels included, respected and has equitable opportunities. Through meaningful recognition and a motivating atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe that you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB .

RANDATUCB

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

Learn moreabout sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.