Global Data Manager Specialist
The Global Data Manager (GDM) Specialist, within the Integrated Data Analytics and Reporting (IDAR) organization, will provide oversight and accountability for multiple low, moderate, and high complexity trials. This individual may also be a member of multiple projects of low, moderate, high complexity or a leader of projects of low to moderate complexity. Make recommendations and decisions that have an impact on specific trials or assignments. Make decisions for processes, timing, and structure for trials and assignments. Make recommendations for processes, timing, structure, and resources at a program level. This position will analyze, provide recommendations, and make decisions with minimal direction from manager or Data Management Leader (DML).
This position will collaborate with vendors/Contract Research Organizations (CROs) and Senior GDM to achieve successful, cooperative partnerships. Recognize opportunities and contribute to solutions to strengthen the vendor/CRO relationship. The GDM Specialist will mentor and coach GDMs and Senior GDMs on trial level responsibilities and may delegate work.
- Take a leadership role with the CRO, the trial customer(s), Senior Global Data Manager and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Identify and communicate ways to improve deliverables.
- With the trial customer, CRO, GDM, and other functional partners: take a leadership role to gather content and integration requirements for electronic Case Report Form (eCRF) and other data collection tools; lead conventions and quality expectations for clinical data; lead expectations for dataset content and structure; set timeline and follow‐up regularly to ensure delivery of all data management milestones.
- Ensure trial level oversight controls are performed as described in the oversight plan, Quality Control (QC) process, and work instructions.
- Ensure that clinical data management documents are reviewed accurately (including submission package) to facilitate appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.
- Oversee the assessment of real‐time inspection readiness of all data management deliverables for the trial. Participate in regulatory agency and J&J internal audits as necessary.
- Lead the planning and tracking of content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensure deliverables are on time.
- Take a leadership role with the assigned clinical working group(s) to ensure that Data Management (DM) and Therapeutic Area (TA) trial needs and deliverables are met. Collaborate with the DML to develop scope of work and identify needed resources. Work with Infrastructure Organization to ensure all deliverables are effectively completed.
- Take a leadership role to obtain and share best practices with internal partners. Lead others in implementing process, system, and tool improvement initiatives within DM.
- Present information and train investigators and site monitors.
- A minimum of a Master'’s degree in a Scientific discipline or PhD degree is preferred.
- A minimum of 5 years of data management experience is required.
- Experience in clinical drug development within the Pharmaceutical industry, Contract Research Organization or related industry is required.
- Experience with Electronic Data Capture (i.e. Medidata Rave, Inform) platforms preferred.
- Vendor oversight experience is preferred.
- Team leadership experience is preferred.
- Experience leading a change in data management techniques and/or processes preferred.
- Project management experience is preferred.
- Must have excellent verbal and written communication skills.
- Must have the ability to adapt to a rapidly changing organization and business environment.
- The ability to collaborate with all levels of management across a matrix environment is required.
- This position will require up to 10% travel.
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-SwitzerlandOrganization
Janssen Pharmaceutica N.V. (7555)Job Function
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