Senior Study Data Manager

Rockville, MD
April 27 2021
Organization Type
Job Type
Site Name: USA - Maryland - Rockville Posted Date: Apr 27 2021 The Senior Study Data Manager is responsible for coordinating the end to end Data Management study related activities on a day to day basis and is the ultimate accountable of all DM 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. 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 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 Provides DM operational input into the study design, the clinical protocol, study planning and review of study documents Create study level timelines for DM deliverables and ensures teams adhere to them Member of the study core team and acts as the single point of contact for all the DM study related activities & matters Provides reports, status updates, feedback and advice to key study stakeholders on study progress. Provides input into the Study Risk Registers for all study DM risks Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalated as required to the Oversight Data Manager (the ODM will communicate to the CECT on any issues if applicable) Ensure DM study deliverables are in compliance with GSK SOPs and regulatory guidelines The Senior Study Data Manager has the accountability for 1 or several complex studies, and performs the full set of activities of the Study Data Manager (see Job description of SDM) and has 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). The Senior Study Manager acts as a mentor & reference model within the Study Data Management Team The Senior Study Data Manager leads the implementation of new processes, provide ownership on associated written standards & trainings, vendor quality assessments, audits and inspections Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Masters or equivalent: Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent 4+ years of experience in Data Management. Clinical Research or Information Systems experience with end to end study responsibility. Experience with Project Management including risk & time management Experienced in Data Management and Clinical Systems Fluent English (written and spoken) Preferred Qualifications: 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 Fluent with CDISC requirements Understanding of general data flow & database architecture concepts Good understanding of regulations including ICH-GCP Exposure to novel technologies is an asset (eDiaries, eCOnsent, eProtocol, Veeva, Power BI Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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