EDC Systems Manager
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland) and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for an EDC Systems Manager who could also take on a Data Warehouse Manager role.
- The EDC Systems Manager is a functional expert in the field of Oracle InForm Electronic Data Capture (EDC) and related systems. As such, they support activities and responsibilities related to the management of Galapagos’ (GLPG) EDC system Oracle InForm and its associated applications, from initiation of contract for the trial’s EDC environments up to archival of the trial database.
- The Data Warehouse Manager is a functional expert in the field of SAS Life Science Analytics Framework (LSAF) - Data Warehouse solution. As such, they support activities and responsibilities related to the management of Galapagos’ (GLPG) LSAF system and possibly of associated applications.
As an EDC Systems Manager, you will:
- Create GLPG Data Management (DM) Leaders in the Central Designer Administrator (CDA) application as applicable
- Coordinate study preparation steps, such as study level contracting with Oracle, documentation sharing with Oracle and the selected DM Contract Research Organization (CRO), and sending required requests to Oracle to prepare the DM CRO for their tasks
- Create study in Central Designer (CD) and related skeleton trials in Design Environment Cloud Service (DECS) and create and assign DM CRO Users to the study
- Manage the User Management Tool (UMT) and the Clinical One/Health Services (HS) Learn
- Ensure integration with the Central Coding (CC) Tool is set up, as well as other needed integrations, such as with an Integrated Voice/Web Response System (IxRS), and handle related Identity and Access Management Service (IAMS) requests
- Approve deployment packages when needed
- Ensure Post Go-live Changes are properly handled when applicable
- Ensure proper use of CRF Submit to generate subject data and manage database decommissioning
- Perform general maintenance steps for DECS, CDA, CD, UMT, CC, and the InForm Portal
- Manage eCRF libraries when instated
- Provide expectations, information and further support to DM CRO and GLPG internal users and work closely with the vendor for additional support when needed; set up information sharing or training sessions when needed
- Work closely with the vendor on any upcoming maintenance or system upgrades; collaborate in impact assessment, and involve GLPG in required actions as appropriate; support any system validation related activities
- Participate in Industry user groups to stay informed of upcoming system updates and best practices
- Adhere to relevant policies and procedures and ensure timely completion of relevant training
- Interact with Quality to follow up on audit and inspection reports and Corrective Action/Preventive Action plans in a timely manner; participate in audits and inspections where needed
- Lead or contribute to any activities related to procedural documents and Process Improvement initiatives as required
Who are you?
- The successful candidate has a Masters’ degree and has at least 6 years’ experience in a pharmaceutical/biotech environment (and/or relevant experience with a large CRO).
- You are able to organize and plan multiple priorities, and to coordinate external service providers.
- Furthermore, you have good knowledge of applicable regulatory guidelines and of Clinical Data Management Systems and supportive software.
- Having Clinical Data Management experience is a plus for this role.
- Last but not least, you enjoy contributing to our Quality Management System with respect to Data Management, and working in cross-functional teams.
- Of course, your English oral and written communication skills are excellent!
What’s in it for you ?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ 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…!