Associate Director/Director, Data Management
PepGen
- Boston, MA
- Permanent
- Full-time
The Associate Director/Director of Data Management (DM) will act as the DM lead of several programs with accountability for all DM activities including study set-up, review, cleaning, and delivery of clinical data. This role is responsible for timely and high-quality data management deliverables supporting the clinical development, regulatory submissions, and inspections at PepGen.Responsibilities
- Oversees and directs clinical data management (CDM) activities across multiple studies and compounds.
- Participates in the development/review of all CDM end-to-end activities including eCRFs, CRF Completion Guidelines, Data Management Plans, Edit Checks, Data Review Plans, Data Transfer Specifications, maintenance of clinical study database, as well as oversight of data finalization and database lock activities, etc.
- Helps manage the performance of CROs and other third party vendors.
- Participates to best practices initiatives, identify the need, and participate to the creation of functional standard operating procedures (SOPs), Work Instructions, job aids, and other training documents.
- Leads data cleaning activities such as study team data reviews, SAE reconciliation, non-CRF data reconciliation, non-system edit checks.
- Provides direction and guidance to team members, including consultants and vendors to achieve/meet corporate goals and milestones.
- Oversees the tracking of important study metrics on data entry, source data verification, query status, data trends and presents these metrics to a cross-functional team as required.
- Proactively identifies risks and executes risk mitigation strategies; Maintains timely communication with management and cross-functional teams.
- Master’s Degree preferred or bachelor’s degree with extensive years of DM work experience in the pharmaceutical or biotechnology industry required.
- Thorough knowledge/understanding of the principles of clinical research, ICH, GCP, GCDMP, CDASH/SDTM, and other regulatory standards.
- Demonstrated project management experience with ability to perform under tight timelines while balancing conflicting priorities.
- Experience working with and managing external service providers/vendors.
- Cross collaboration proficiency with other functional areas with ability to work effectively in a team setting, as well as independently.
- Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and projects seamlessly with excellent attention to detail.
- Flexible with excellent problem-solving and negotiation skills.
- Relevant therapeutic experience in rare diseases desired.
PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit or follow PepGen on Twitter and LinkedIn.EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.Powered by JazzHR