Open Position
Title: Data Management Lead
Location: Morrisville, NC
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Role
The Data Management Lead is responsible for providing leadership of clinical data management activities across one or more clinical development programs enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.
Key Responsibilities
–– A key role (Data Management Lead) that serves as the primary point of contact to the wider clinical trial team for clinical trial data related matters.
–– Coordinate activities across clinical data management, to ensure cohesive support to clinical trial data collection, review, and reporting.
–– Maintain a consistent approach to the gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, external lab/vendor files, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness at all times.
–– Serves as the critical issue point for unresolved data issues; work with client/in house data managers, vendors, internal team members for resolution.
–– Leading activities with external vendors developing systems/applications for clinical trial data collection (e.g. EDC, IRT, external lab/vendor data) to ensure quality and timely deployment.
–– Implementation of the Data Management Plan (DMP) defining and documenting the data review strategy for each clinical trial in collaboration with various stakeholders (e.g. statistics, safety, etc.), enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities..
–– Ensuring effective quality oversight and management of external partners (e.g., CROs, technology providers, etc.) performing data management services on behalf of TG Therapeutics.
–– Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.
–– Participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.
–– Developing strong and productive working relationships with key stakeholders throughout TG Therapeutics, with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
–– Collaborate effectively on defining standardized procedures/processes as they apply to Data Management.
Professional Experience/Qualifications
–– At least 7 years of relevant clinical data management lifecycle experience; DM lead experience preferred.
–– Diverse and sufficient technical expertise to be a credible interface to all global development and business partners.
–– Knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
–– Immuno-Oncology therapeutic experience is highly desirable.
–– Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices.
Education
Bachelor’s degree required with an advanced degree preferred.