Rocket Pharmaceuticals

Senior Director, Data Management

Location US-NJ-Cranbury
ID 2024-1940
Category
Biometrics
Position Type
Regular Full-Time

Overview

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.

Position Summary

As the Senior Director, Data Management, the person in this position will be accountable for all aspects of Data Management. The incumbent will provide clinical data management expertise and leadership, and be responsible for developing and implementing Data Management processes consistent with regulatory requirements and best industry practice, planning and managing data management resources to meet business needs across all clinical programs, overseeing data management vendors, and ensuring high-quality completion of databases and data deliverables in close collaboration with other functions.

Responsibilities

  • Accountable for all aspects of Data Management, including Data Management strategy, talent, processes, project timelines, data quality and integrity.
  • Develops and implements processes (e.g., SOPs and WIs) and standards consistent with regulatory requirements and best industry practice for Data Management function with an outsourcing model; contributes to development of cross-functional processes and standards
  • Leads cross-program productivity and compliance initiatives in Data Management
  • Collaborates effectively with other functions (e.g., Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics, Statistical Programming) to advance Data Management initiatives and program/study goals
  • Provides strategic and technical expertise in clinical data management for clinical development programs and regulatory submissions
  • Forecasts and manages Data Management resources to meet current and future business needs
  • Selects and manages vendors for EDC and related services to meet GCP and regulatory requirements, quality standards, timelines and budget constraints
  • Ensures (through team members or directly) that EDC (including eCRFs, DVS/edit checks, DMP, eCCG) meets protocol requirements while adhering to established Data Management processes
  • Ensures (through team members or directly) that database updates, data reconciliations between EDC and other sources, and ongoing data entry and cleaning are reasonably up-to-date to enable high-quality data snapshots and soft locks to support various program/study activities
  • Ensures (through team members or directly) that database lock activities are completed per project timeline while adhering to established Data Management processes to achieve high quality data deliverable with proper documentation and inspection readiness
  • Devises or oversees development of database metrics to inform cross-functional teams and support vendor oversight
  • Anticipates new challenges, risks, and needs for Data Management, and proactively mitigates to ensure business continuity
  • Responsible for recruiting, coaching, mentoring, and performance management of direct reports

Qualifications

  • Bachelor's degree or higher, preferably in a scientific area or health related discipline.
  • 15 years of experience in pharma/biotech industry, with majority in clinical data management
  • 5+ years of experience in managing a Data Management team, including responsibility for projects as well as hiring, managing, mentoring and/or developing direct reports
  • Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
  • Extensive experience in managing an outsourced data management model
  • Extensive experience with Medidata RAVE
  • Familiarity with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
  • Familiarity with CDASH and SDTM standards
  • Experience in leading Data Management for a BLA or NDA
  • Excellent written and oral communication skills
  • Ability to prioritize and multi-task effectively
  • Ability to collaborate, communicate and interact effectively in a fast-paced team environment

EEO Statement

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed