Senior Specialist - Study Data Manager
- Amsterdam, Netherlands
Site Name: Netherlands - Amsterdam
Posted Date: Jul 8 2020
Job Purpose: As the Senior Study Data Manager, you are responsible for coordinating the end to end Data Management (DM) study related activities on a day to day basis and is the ultimate accountable of all Data Management study deliverables in terms of quality & delivery to plan. This role acts as the DM representative at the study core team and is also able to guide Study Data Managers in their tasks.
- You are responsible for coordinating the end to end Data Management study related activities on a day to day basis and is the ultimate accountable of the Data Management (DM) study deliverables in terms of quality & delivery to plan:
- Electronic Case Report Form and (electronic) Diary Cards
- Data Management Plan & associated documents
- Data Management Report
- Interim and final cleaned database freeze
- Archival of all DM documents in the eTMF
- Archival of the study database and provision of clinical data to the study site
- You Provide DM operational input into the study design, the clinical protocol, study planning and review of study documents
- You create study level timelines for DM deliverables and ensures teams adhere to them
- You are a member of the study core team and act as the single point of contact for all the DM study related activities & matters
- You provide reports, status updates, feedback and advice to key study stakeholders on study progress
- You provide input into the Study Risk Registers for all study DM risks
- You act as the first point of escalation for all DM study issues. Understand, mediate and solve issues related to DM study deliverables and escalate as required to the Oversight Data Manager (the ODM will communicate to the CECT on any issues if applicable)
- You ensure DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
- As the Senior Study Data Manager, you have the accountability for 1 or several complex studies, and perform the full set of activities of the Study Data Manager (see Job description of SDM) and have the ability and the seniority to manage the delivery of any type of studies (different areas, complex/unusual early setting, new/unusual indication, pivotal / Phase III and efficacy studies, clinical as well as epidemiology).
- You act as a mentor & reference model within the Study Data Management Team & the implementation of new processes, provide ownership on associated written standards & trainings, vendor quality assessments, audits and inspections
We are looking for professionals with these required skills to achieve our goals:
- Masters or equivalent in Engineering, Life Sciences, Computer Sciences, Mathematics and/or Physics
- Minimum 4 years of Data Management. Clinical Research or Information Systems experience with end to end study responsibility
- Good Project Management including risk & time management skills
- Experienced in Data Management and Clinical Systems
- Fluent with CDISC requirements
- Understanding of general data flow & database architecture concepts
- Good understanding of regulations including ICH-GCP
- Fluent English (written and spoken)
If you have the following characteristics, it would be a plus:
- Excellent communication, influencing and negotiation skills within a matrix environment
- Good problem solving and project delivery skills
- Exposure to novel technologies is an asset (eDiaries, eCOnsent, eProtocol, Veeva, Power BI)
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