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
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 in an audit-ready state
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

Requirements

Bachelor’s Degree in health-related field
Minimum of 8 years of clinical data management in pharma/biotech/healthcare industry
Must be able to demonstrate extensive experience in the design, execution, collection, and cleaning of data for clinical studies
Technology proficiency including Data Management Systems. Knowledge of clinical research including regulatory requirement 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
Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
Ability to keep pace in a fast-moving organization and navigate ambiguity
Experience working with in a remote virtual environment
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year.

Benefits

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
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
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementdata collectiondata cleaningdatabase managementdata review systemseCRF designCDASHregulatory submissiondata visualizationdata governance

Soft Skills

leadershipcommunicationcollaborationadaptabilityproblem-solvinggrowth mindsetpsychological safetyorganizational skillsattention to detailtime management

Certifications

Bachelor’s Degree in health-related fieldGood Clinical Practice (GCP)ICH Data Quality certification