Associate Director, Data Management
Cranbury, NJ /
Clinical Operations – Data Management /
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
The ideal candidate will have diverse Data Management (DM) leadership experiences, will be hands on and driven to direct and contribute broadly to DM functional initiatives and actively participate in the development, implementation and oversight of strategic plans.
- Lead for assigned projects:
- Establishes and meets project management requirements by incorporating cross functional processes with clinical operations, medical, clinical science, biostatistics, regulatory, etc.
- Assist in the development and implementation of data management standard working practices along with preparations and requirements for regulatory inspections and or submissions.
- Direct the coordination, gathering, planning, implementation and process improvement necessary to meet any cross functional data quality requirements for conducting trials.
- Comprehend and translate clinical team objectives into operational actions and maximize available technical platforms to assist in completing project objectives.
- Responsible for vendor performance, deliverables and key measures
- Organize and maintain operational continuity with other studies and programs
- Contribute toward establishing global data standards and authoring standard operating procedures
- Participate in reviews of budgets and or invoices
- Data Management Trials Lead:
- Serve as DM project manager/lead managing assigned study project timelines and ensure deliverables/timelines 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, IDSMC, etc. from a data management perspective
- Handle Data Management deliverables including 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.
- Review of electronic case report forms (eCRFs) for completeness, content and database considerations
- Proficient in CDASH/SDTM and facilitates the meeting of data standardization
- Responsible for ensuring QC of outputs and data standards transformations are appropriately validated and documented
- Perform and head up cross functional 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
- Creates outputs and metrics to track and report data/query status
- Assist in creating data visualizations, as required, for presentations
- BS in scientific, healthcare, medical and or bioinformatics/computer science discipline.
- 8+ years of proven career development, growth, advanced skills and accomplishments
- Must have relevant project initiatives leadership and or supervisory experiences in clinical data management in the pharmaceutical/biotechnology industry
- Past experiences with inspection readiness, regulatory submission and strong CRO oversight
- Excellent organizational skills, highly collaborative & supportive, attention to detail, communication, time management, and flexible attitude with respect to work assignments
- Embraces new learning and demonstrates strong ability to communicate and interact in a team environment
- Knowledge of industry and regulatory standards (FDA and/or EMEA Regulations, ICH Guidelines, and GCP)
- Proficient in multiple EDC platforms, related processes and data visualization/graph tools, i.e.: Power BI, Tableau, SAS VA, GraphPad, etc.
- Working knowledge of SAS, SQL, database design and database concepts
- Strong knowledge of CDISC standards (CDASH/SDTM)
- Progressive minded, very organized and creative problem solver
- Knowledge of related regulations, GCP and Good Clinical Data Management Practices
- Skillful with medical terminology and advanced background in labs
- Understanding of coding (MedDRA, WHO drug dictionaries)
- Comfortable in a fast-paced small company environment with 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.
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.