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Associate Director, Data Management

3 hours, 1 minute ago
United States
Full-time
Lead
Database Administrator
Database Administration
GCP
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 17

Description

  • Provide operational leadership for the direction, design, planning, execution, collection, and handling of clinical trial data to the highest quality standards.
  • Coordinate and participate in clinical data review, including support for data review systems, process development, guideline creation, and custom database reporting.
  • Ensure clinical data quality in EDC systems at database snapshots and database locks, including documenting and managing related processes.
  • Work with CROs to prepare and ensure proper execution of data management activities.
  • Review protocols to assess database feasibility.
  • Oversee CRO data management deliverables and external data management partners.
  • Ensure eCRFs, database interfaces, programmed edit checks, external data files, and CRF completion guidelines are designed and built in a standard, accurate, complete, and consistent format.
  • Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed.
  • Partner with Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver high-quality data in a timely manner.
  • Maintain documentation and archival standards for data management deliverables and keep project documentation audit-ready.
  • Ensure clinical trials have complete and accurate supporting documentation for regulatory submissions, including raw datasets and annotated CRFs.
  • Develop, maintain, and govern CDM standards such as standard eCRFs and CDASH.
  • Ensure data management activities comply with GCP, GCMP, internal SOPs, and regulatory requirements.

Requirements

  • Bachelor’s degree in a health-related field.
  • Minimum 8 years of clinical data management experience in pharma, biotech, or healthcare.
  • Extensive experience designing, executing, collecting, and cleaning data for clinical studies.
  • Strong technology proficiency, including data management systems.
  • Knowledge of clinical research regulatory requirements, including GCP/ICH and data quality standards.
  • Extensive experience managing CROs and other data vendors.
  • Submission experience with NDA, sNDA, and BLA filings.
  • Knowledge of Good Clinical Practice.
  • Experience with EDC and eCOA systems such as Medidata and Veeva.
  • Excellent written and oral communication skills.
  • Strong leadership skills with a growth mindset and the ability to foster a psychologically safe environment.
  • Ability to work in a fast-moving organization and navigate ambiguity.
  • Experience working in a remote virtual environment.
  • Ability to travel up to 15%, including mandatory in-person attendance at All Hands meetings twice per year.

Benefits

  • Anticipated base salary range of $180,000 to $195,000.
  • Market-competitive compensation package with performance bonus opportunities.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to resources for growth.

Interested in this position?

Apply directly on the company website

Apply Now

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