Senior Manager, Clinical Data Management
The ideal candidate will have diverse data management and clinical trial experiences, being hands-on and motivated to support and contribute broadly to Data Management functional initiatives, and actively participate in the development, implementation, and management of data collection, ensuring its highest quality and integrity. Motivated and willing to work in partnership, guide and support cross-functional teams, and apply dynamic and creative approaches in the lifecycle of clinical trial data.
What You'll Do
- Provides leadership in establishing and meeting project management requirements by incorporating cross-functional processes with clinical operations, medical, clinical science, biostatistics, regulatory, quality compliance, etc.
- Assist in the development and implementation of data management standard working practices along with preparations and requirements for regulatory inspections and or submissions.
- Responsible for vendor performance, deliverables, and key measures
- Comprehend and translate clinical team objectives into operational actions and maximize available technology platforms to assist in coordination, planning, and completing objectives.
- Contribute toward establishing global data standards and governance, and authoring practices
Data Management Lead (directly and/or through vendor management)
- Delivers content expertise as DM project manager/lead managing assigned study project timelines ensuring overall deliverables/timelines and vendor responsibilities are met
- Provide leadership and content expertise for DM activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
- Provide input into study protocols, SAPs, DSMB, etc. from a data management perspective
- Handle data management deliverables including document creation of Data Management Plans, Data Validation Specifications, CRF Completion Guidelines, Transfer Specifications, Lab Specifications, etc.
- Participate with vendors in UAT for database builds and or migrations to manage any impacts from mid-study updates to the EDC database.
- Provides electronic case report forms (eCRFs) utilizing the Spero Standards Library and reviews updated designs for completeness, content, and database considerations
- Facilitates meeting CDASH/SDTM data standardization guidance
- Responsible for ensuring QC of outputs and data standards transformations are appropriately validated and documented
- Perform data reviews for quality issues and general data trends
- Establish data transfer guidelines for external data with CRO and vendor partners; ensure transfers and reconciliations are to plan
- Manages outputs and metrics to track and report data/query status
What You'll Need
- 8+ years of proven career development, growth, and accomplishments in clinical data management/clinical trials; BS in scientific, healthcare, medical, and or bioinformatics/computer science discipline.
- Must have relevant technical skills, CRO oversight, and QA/QC; submission preparation experiences within the pharmaceutical/biotechnology industry is preferred.
- Excellent organizational skills, highly collaborative & supportive, attention to detail, communication, time management, and flexible attitude with respect to work assignments and new learning with proven ability to interact in a team environment.
- Proficient in data collection/reporting/analysis, related processes in using multiple EDC platforms (i.e., Medidata, ePRO, RDMSs, etc.)
- Moderate to the strong background with CDISC standards (CDASH/SDTM)
- Knowledge of industry and regulatory standards (FDA and/or EMEA Regulations, ICH Guidelines, and GCP)
- Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
- Self-starter and must function well under minimal supervision
- Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides, and templates, in addition to Adobe Acrobat.
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