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Job Description
Key Responsibilities
Align Data & Statistical Science (DSS) study teams with program & study-level strategies.
Lead the DSS Study Team & represent DSS as a member of cross-functional study team.
Act as single point of contact & accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives.
Utilize clinical trial systems including Electronic Data Capture (EDC), Interactive Response Technology (IRT) & Clinical Trial Management Systems (CTMS).
Utilize understanding of Laboratory data, Clinical Outcomes Assessments (COA/eCOA), ECG, IRT, Pharmocokinetic & other external data types.
Engage & connect global functional & cross-functional teams at study level. Interact with & influence cross-functional team members to achieve program objectives.
Plan, coordinate, & deliver data management tasks within timeline.
Utilize operational analytics & project management tools to optimize execution of programs & studies, manage internal & external resources, track study progress, & prepare study status reports.
Author, revise, & review data management related plans & documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), & completion Guidelines.
Anticipate & identify issues that could affect timelines or quality & develop options & solutions, identify & mitigate risk and contribute to Risk Assessment & Management Plan.
Ensure adherence to federal regulations & applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), & functional quality standards.
Perform project management skills including metrics analysis & reporting methodologies.
Keep abreast of new &/or evolving local regulations, guidelines & policies related to clinical development.
Participate as DSS study owner in regulatory inspections & internal quality audits.
Participate in oversight of vendors & provide feedback related to clinical trial operations, issues, & trends in performance.
Utilize reporting & data visualization tools such as Spotfire, J-Review, Business Objects &/or SAS to generate data review listings, also, project management tools such as Microsoft Project, Smartsheet or equivalent.
Responsible for coaching & mentoring team members.
Lead DSS innovation & process improvement initiatives & participates in cross-functional initiatives.
Conduct study execution across functions.
Conduct indirect supervision of employees as well as supervision of work of contract resources.
