One of Real Staffing's top Pharmaceutical clients in northern New Jersey is seeking an Expert Clinical Data Manager to join their team for a 12 month contract project.
The Title and Department:
Expert Data Manager, Medical Affairs Oncology Strategic Business Unit
Provide data management support and expertise for Medical Affairs Oncology SBU studies.
- Serves as the key subject matter expert on topics related to data management activities. Contributions include, but are not limited: vendor selection and management, leading or contributing to expert working groups (e.g., processes, OIs, etc.), presenting best practices at internal and external meetings.
- Governs use of key data management elements across studies in assigned project: assumes ownership of development and maintenance Medical Standards relevant to the area of responsibility (GMSIT AS/CPS/Codelists); provides data structure standards; review application of the Important Medical Event (IME) List, medical coding conventions, and standard coding rules.
- Ensures adequate application of Data Management Best Practices across studies within assigned project: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs.
- Provides oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing , synergies, change orders, etc.), vendor selection and management, risk and communication management, and application of best data management practices.
- Advises on resource planning/allocation based on forecasted activities per the Medical Affairs Plan and actual study/project metrics.
- Supports the development and implementation of Project and Study Data Management strategic initiatives and activities.
- Contributes to projects and initiatives aimed at improving and optimizing the delivery of Project and Study Data Management.
- Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
- Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs, Operational Instructions (Ols) and Process Guidance Documents (PGDs)
- Bachelor's Degree required
- Master's Degree preferred
- At least 7 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 the DM lead on studies/project(s).
- Deep understanding of the drug development process. Strong organizational skills and able to collaborate with minimal supervision.
- Significant experience of 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 TrialsDirective, Privacy rules (HIPPA).
- Basic SAS Programming knowledge, or other database experience, preferred.
Sthree US is acting as an Employment Business in relation to this vacancy.