Job Description
About Voyager Therapeutics Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of - and ultimately cure - neurological diseases. Our pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit
Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc.
Job Summary: Voyager is seeking a highly motivated Contract Data Management professional to join the Clinical Operations team. This is a part-time (~20 hours per week), 6-month, contract position. The qualified candidate will lead Data Management and play a critical part in developing the function internally.
Responsibilities - Support the initial build of a Data Management function including developing relevant standards, and optimizing CRO relationships.
- Manage relationships with CROs, vendors, and other external partners and participating in CRO/vendor selection for Data Management services and software.
- Oversight of data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines.
- Oversight of CRF Development and build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements.
- Oversight of the establishment and maintenance of Data Management plans and study-specific data quality related documents.
- Ensure that clinical data management activities for clinical trials and regulatory submission projects are completed on time and with high quality.
- Ensure the delivery of clinical trial data of the highest integrity by establishing procedures for ongoing and final data review.
- Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Ensure that CDM study files are organized and accessible during study conduct and that archives are completed after study closeout.
- Contribute to back-end project budget/resource planning, forecasting, program milestones, along with Clinical Operations management.
- Author and review department SOPs as needed.
Qualifications - Bachelor's degree or higher in a scientific discipline; at least 7 years of experience in clinical data management in pharma/biotech.
- Thorough understanding of clinical trials process and regulatory requirements.
- Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
- Advanced Experience managing CROs in data management-related activities.
- Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements.
- Advanced knowledge of the regulations that govern CDM activities.
- Excellent organizational skills and able to adapt to multiple priorities in a fluid environment.
- Excellent verbal and written communication skills.
- Excellent skills in validating EDC databases and performing data review.
- Demonstrated leadership ability and project management skills.
- Ability to use PC and widely used software packages, e.g., Excel, MS Word, SAS programming.
Job Tags
Contract work, Part time, For contractors,