Data Management Director

Summary

Join Apogee Therapeutics as their Director of Data Management and lead all aspects of clinical trial data management. You will oversee data collection, quality control, and regulatory compliance, while mentoring a team of data managers. This role requires extensive experience in clinical data management, CRO management, and regulatory submissions. You will build and maintain data management standards, collaborate with cross-functional teams, and ensure data integrity throughout the clinical trial lifecycle. Apogee offers a competitive compensation and benefits package, including a flexible PTO policy and opportunities for professional development. The company fosters a dynamic and collaborative work environment.

Requirements

• Bachelor’s Degree in health-related field
• Minimum of 10 years of clinical data management in pharma/biotech/healthcare industry
• Minimum of 5 years of direct people management experience, including a remote workforce
• Must be able to demonstrate extensive experience in the design, execution, collection, and cleaning of data for clinical studies
• Technology proficiency in Data Management Systems
• Knowledge of clinical research including regulatory requirements GCP/ICH Data Quality
• Extensive experience managing CROs and other data vendors
• Submission experience (NDA, sNDA and BLAs)
• Knowledge of Good Clinical Practice
• EDC and eCOA experience (Medidata, Veeva, etc.)
• Excellent written and oral communication skills
• Ability to keep pace in a fast-moving organization and navigate ambiguity
• Experience working in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Responsibilities

• Provide operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
• Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
• Ensure the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks
• Responsible for building effective DM vendor relationships including being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed
• Work closely with CROs to prepare and ensure proper development and execution of data management activities
• Review protocols to ensure database feasibility
• Provide effective oversight of all CRO data management related deliverables
• Ensure that eCRFs, database interfaces, programmed edit checks and external data files, CRF completion guidelines are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submissions
• Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed
• Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion
• Responsible for documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is audit-ready
• Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
• Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.)
• Ensure that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements
• Build and mentor a team of data manager(s) to effectively support clinical trials and pipelines

Preferred Qualifications

This position requires up to 10% travel to company and team/functional meetings

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve