Senior Lead Clinical Data Manager
Senior Lead Data Manager - Oncology/Med Affairs
On-site in Whippany, NJ
12 month contract
Oncology Business Unit - Statistics & Data Management. Data Manager serves as the key subject matter expert on topics related to data management activities.
Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, ongoing data review and reconciliation, project data management.
The Senior Lead Data Manager (Sr. LDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The Sr. LDM may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Oncology Data Management on the Core Study Team.
POSITION DUTIES & RESPONSIBILITIES
- The Sr. Lead DM assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and applies Data Management best practices
- Incorporates and maintains Bayer standards in clinical studies and projects for all elements of the medical standards package.
- Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the SDMD, maintaining document
- management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC, etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.
- Specifies and develops study specific eCRFs, database structures and data consistency checks based on medical standards, the Clinical Study Protocol and input from the study team.
- Prepares, tracks and implements standard plans (i.e., GDM Study Plan, Data Management Plan,
- Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities.
- Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final Validity Review Meeting.
- Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.
- - Identifies and issues queries, incorporates query replies, tracks query status.
- Bachelor's degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation
- At least 5 years of study and/or project level experience as a Data Manager in supportive and leading roles.
- At least 2 years of experience should demonstrate responsibility as a study leader.
- Good understanding of the drug development process
- Strong organizational skills and able to collaborate with minimal supervision.
- Basic SAS Programming knowledge, or other database experience
- Significant experience in using data management methodologies and technologies (e.g. data warehousing, electronic data capture)
- Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials
- Directive, Privacy rules [HIPPA], etc.)
Sthree US is acting as an Employment Business in relation to this vacancy.