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Galapagos

Country: Belgium

Specific Location: Mechelen or Netherlands (Leiden)

Job Title: Data Management Leader

Type of Job: Permanent

Job Description:

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company. We’re in the business of changing lives.

Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.

Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies.

We are looking for an enthusiastic and highly motivated Data Management Leader within our Biometrics team.

This position is located in Belgium or the Netherlands.

Scope of the role
The Data Management Leader has solid Clinical Data Management (DM) expertise to take responsibility of oversight activities for Galapagos’ clinical trials, supporting the Clinical Study Team (CST) through managing the collection, review and reporting of clinical data and related activities during the planning, set-up, conduct, and close-out of clinical trials.

Responsibilities:
Participate in CST meetings as DM representative, and closely interact with Biostatistics, Medical, Clinical Operations and other functional representatives
Provide data management expertise during protocol development, including for any amendments
Act as first point of contact for DM CRO counterparts, and ensure clinical study data management deliverables within agreed budget and timelines, and with high quality (complying with Galapagos’ processes, ICH-GCP and applicable regulations and guidelines)
Organize relevant data management oversight meetings, and ensure minutes are documented
Create and maintain Data Management Oversight Plan, and ensure proper execution of necessary risk-based quality control steps
Ensure proper and timely filing of DM-specific documents and files in Trial Master File or other dedicated environment
Actively participate in DM and Biometrics team meetings
Adhere to relevant policies and procedures, and ensure timely completion of relevant training
Interact with Quality & Compliance to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed
Lead or contribute to the DM Subject Matter Expert (SME) Network and/or any Process Improvement initiatives as required
Job requirements

Who are you?
You have a Bachelor or Masters’ degree in a Life Sciences field, followed by at least 6 years’ experience in a pharmaceutical/biotech environment (and/or relevant experience with a large CRO) in a clinical data management or closely related discipline
You have a good understanding of CDISC SDTM
You are able to organize and plan multiple priorities, and to coordinate external service providers
You have a good understanding of the drug development process, applicable regulatory guidelines, and Clinical Data Management Systems
You are a team player, and can work autonomously
Of course, your English oral and written communication skills are excellent!
You are already living/working in Belgium / Netherlands and flexible to work 1d/week in the office depending on your location – either in Mechelen (Belgium) or Leiden (NL)

What’s in it for you?
You will be part of a fast growing and amazing company. You will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos: together we can make it happen…!

Closing Date: October 31, 2022

Website/URL for further details: click here

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