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Associate Director, Data Management

3 weeks, 6 days 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 22

Description

  • Provide operational leadership for the direction, planning, execution, collection, and handling of clinical trial data.
  • Coordinate and participate in clinical data review, including support for review systems, process development, guideline development, and custom database reporting.
  • Ensure clinical data quality in EDC systems at database snapshots and database locks, including related process definition, documentation, and management.
  • Work closely with CROs to prepare and execute data management activities and provide oversight of CRO deliverables.
  • Review protocols to assess database feasibility.
  • Ensure eCRFs, database interfaces, programmed edit checks, external data files, and CRF completion guidelines are designed and built in a standard and accurate format.
  • Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools when needed.
  • Partner with cross-functional teams including Clinical Operations, Regulatory, and Pharmacovigilance to deliver high-quality data on time.
  • Maintain documentation and archival standards for Data Management deliverables and keep project documentation audit-ready.
  • Ensure clinical trials have complete 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 of 8 years of clinical data management experience in pharma, biotech, or healthcare.
  • Extensive experience in the design, execution, collection, and cleaning of clinical study data.
  • Proficiency with data management systems and knowledge of clinical research regulatory requirements, including GCP and ICH data quality standards.
  • Extensive experience managing CROs and other data vendors.
  • Submission experience with NDA, sNDA, and BLA filings.
  • EDC and eCOA experience, including platforms such as Medidata and Veeva.
  • Excellent written and oral communication skills.
  • Strong leadership skills with a growth mindset and the ability to promote a psychologically safe environment.
  • Ability to thrive in a fast-moving, ambiguous, remote virtual environment.
  • Willingness and ability to travel up to 15%, including mandatory in-person attendance at All Hands meetings twice per year.
  • Experience in clinical data management within a remote work environment (preferred).
  • Alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Benefits

  • Anticipated salary range of $180,000-$195,000.
  • Market-competitive compensation package with base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year and dedicated paid sick leave.
  • Opportunities for professional growth and access to resources to support development.
  • Regular all-team in-person meetings to build relationships and solve problems.
  • Fast-paced, highly dynamic work environment with the opportunity to help shape the company culture.

Interested in this position?

Apply directly on the company website

Apply Now

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