Study Data Manager

    • Rockville, MD

Site Name: USA - Maryland - Rockville
Posted Date: Apr 16 2020

As the Study Data Manager, 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 all Data Management study deliverables in terms of quality and delivery to plan. This role acts as the DM representative at the study core team at GSK's Rockville Slaoui Center for Vaccines Research (SCVR) site.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :

  • 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.
  • Specific deliverables: 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.
  • Provide 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.
  • Member of the study core team and acts as the single point of contact for all the DM study related activities & matters.
  • Provide reports, status updates, feedback and advice to key study stakeholders on study progress.
  • Provide input into the Study Risk Registers for all study DM risks.
  • Act 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.
  • Develop and maintain excellent professional relations with the study teams and other key stakeholders.
  • Act as Subject Matter Expert in supporting Business Excellence in the implementation of new processes 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:
  • Master's degree, specific to Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
  • Minimum 2 years of Data Management. Clinical Research or Information Systems experience with end to end study responsibility 7+ years' experience in EHS field with progressive roles and responsibilities, including managing and executing EHS programs.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:
  • Able to deliver presentations with clarity in various settings (Investigator meetings, local functions and study team levels).
  • Applies effective verbal and written communications skills for specific study activities (e.g., study core team meetings, Risk Registers, Data Management Reports)
  • Able to explain routine DM issues with customers or to a non-technical audience.
  • Provides Data Management expertise in specific technical processes or areas. (e.g., Protocol, Risk Based Monitoring, etc.).
  • Ensures compliance with GSK's principles of data integrity in support of building sustainable public trust and maintaining GSK's corporate reputation long-term.


Why GSK?
Our values and expectationsare 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

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