- 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, authoring standard operating procedures/work instructions, and implementing them
- Participate in reviews of budgets and/or invoices
- Provide coaching and mentoring of data management standards, tools and processes to less experienced data managers
- 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, DSMC, etc. from a data management perspective
- Responsible for the completion or review/approval of Data Management deliverables including Data Management Plans, Data Validation Specifications, CRF Completion Guidelines, Transfer Specifications, Lab Specifications, etc.
- Responsible for the completion and/or oversight of 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, capturing data required by protocol and adherence to standards and database considerations
- Facilitates the meeting of data standardization based on CDASH/SDTM standards
- Responsible for ensuring QC of outputs and data standards transformations are appropriately validated and documented
- Perform and lead 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
- Bachelors degree scientific, healthcare, medical, and or bioinformatics/computer science discipline.
- 12 years of proven career development in clinical data management/clinical trials
- Experience in leading studies in multiple therapeutic areas
- 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 including Medidata Rave, related processes and data visualization/graph tools, i
- 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.
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Associate Director, Data Management - Cranbury, United States - Rocket Pharmaceuticals
Description
OverviewWork 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.
Position SummaryThe Associate Director, Data Management will be hands on and driven to direct activities for assigned programs/studies.
Reporting to the Senior Director, Data Management, they will also contribute to Data Management functional initiatives and actively participate in the development, implementation and oversight of strategic plans.
Responsibilitiese:
Power BI, Tableau, SAS VA, GraphPad, etc.
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.
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