About Rocket Pharma
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.
Position Summary:
The ideal candidate will have diverse data management and clinical trial experiences, being hands on and motivated to support and contribute broadly to DM functional initiatives and actively participate in the development, implementation and management of data collection ensuring its highest quality and integrity.
Primary Responsibilities:
Lead for assigned projects:
- 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 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 technical platforms to assist in coordination, planning and completing objectives.
- Contribute toward establishing global data standards 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, DSMC, etc. from a data management perspective
- Handle the generation of 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
- 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
- Assist in creating data visualizations, as required, for presentations, data monitoring reviews
Education/Experience and Skills Requirements:
- 7+ 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, QA/QC, and submission preparation experiences within the pharmaceutical/biotechnology industry.
- 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, Medrio, ePRO, LIMs, etc.)
- Worked 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 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.
Preferred Qualifications
- Progressive minded, very organized and creative problem solver
- Past experiences with regulatory inspection readiness and data standards implementation
- Trained or certified in Good Clinical Data Management Practices, CDASH and or SDTM
- Data analytics/visualization/graph tools (SAS, Tableau, Qlik, GraphPad, etc.)
- Understanding of coding (MedDRA, WHO drug dictionaries)
- Skilled in labs management and medical terminology
- Ability to effectively lead
- Ability to develop and execute strategies
- Handle issues appropriately and with a sense of urgency
- Strong leadership to support a multi-project environment in small biotech or large pharma
- Ability to interact, cooperate and motivate across departments and functions
Location: Cranbury, NJ
In addition to competitive base salary/target bonus, position includes excellent health and other benefits including 401K. This is an opportunity to become an integral part of a small, highly productive team committed to advancing multiple gene and cell therapies for rare and devastating diseases, and to contribute to the growth of a scientifically-driven and entrepreneurial organization that is increasingly recognized as a leading biotechnology innovator.
EEOC
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.