Clinical Database Developer

Seize your opportunity to make a personal impact as a Clinical Database Developer supporting the Office of Regulated Activities. This is your place to make meaningful contributions to challenging projects and grow a rewarding career. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.

Responsibilities (include but are not limited to):

• Be responsible as a performer or an oversight Clinical Database Developer across multiple projects for the following, but are not limited to, data management activities and deliverables in various phases of the clinical trial lifecycle (e.g., pre-study start, study start up, study conduct, and study closure):

• Participation in the review of SOPs, work instructions, policies, manuals/user guides, and documents related to data collection and management activities and testing and validation documentation of data management systems.

• Participation in the protocol review (from the initial drafts to finalization and subsequent amendments).

• Creation and maintenance of mock electronic case report forms (eCRFs) for electronic data collection method or CRFs for paper-based data collection method designed conforming to the required study data standards and the protocol-specific requirements and objectives.

• Participation in the creation and maintenance of Data Management Plans (DMPs) describing the processes and procedures governing the data management activities for producing data management deliverables.

• Participation in the creation and maintenance of Data Validation Plans (DVPs) outlining quality control checks on CRF data that will be performed manually or programmatically within or externally from the protocol-specific data management databases.

• Design, development, testing, validation, and maintenance of protocol-specific data management databases meeting and conforming to the approved mock eCRFs (or similar documentation listing the agreed data point collection) or approved database modification requests (post-go live), required study data standards, the protocol-specific requirements and objectives, applicable regulations and guidelines, and the respective systems capabilities and requirements:

• Design, creation, and maintenance of protocol-specific data management database design specifications defining data definitions and structure conforming to the applicable study data standards, visit and form workflow and dynamic generation, warning flag and query generation edit checks, and monitoring/tracking status parameter settings.

• Preparation and setup of database instances for development testing, User Acceptance Testing (UAT), training, and production.

• Creation and maintenance of protocol-specific data management database testing and validation documentation:

• Testing and Validation Plan describing the testing, validation, and documentation processes and procedures in the development testing phase, internal data management team testing phase, and User Acceptance Testing (UAT) phase.

• Supporting testing and validation documentation (e.g., test cases/scripts, testing results/findings logs/summary, query listing, data outputs, data extractions, data dictionary, annotated CRF).

• Creation and maintenance of request, approval, and testing and validation documentation for all protocol-specific data management database modifications implemented after the initial release for production.

• Conduct of development testing and UAT.

• Participation in the creation and maintenance of request and approval documentation for protocol-specific data management database production releases and locking/unlocking.

• Creation and maintenance of technical support plans describing the scope and level of support for end users on protocol-specific data management database technical issues.

• Creation and maintenance of training support plans describing the scope and level of support on protocol-specific data management databases.

• Participation in the preparation, conduct, and documentation of protocol-specific data management database trainings with end users on, including but are not limited to, data entry, source verification, query management, data management, reporting and data outputs, eCRF approval, and medical coding.

• Participation in the creation and maintenance of the essential data management documents, including but are not limited to, CRF Completion Instructions, Data Entry Guidelines, Medical Coding Conventions, Self-Evident Corrections, Data Handling Conventions, Data Clarification Forms (DCFs), and Data Management Deliverable Checklist and Tracking.

• Participation in defining specifications and generation of reporting and data exports/outputs (e.g., metrics reports, SAS datasets, customized data listings in Excel format).

• Participation in defining system integration requirements and specifications, testing and validation implementation, and integrated data handling and reconciliation plans (e.g., Interactive Response Technologies (IRT), Electronic Clinical Outcome Assessment (eCOA)).

• Review of external Data Transfer Plans/Agreements and the supporting transfer specifications, testing and validation documentation (e.g., Central Laboratory, eCOA, Pharmacokinetics (PK)).

• Participation in the protocol-specific data management database closure, project closure, and study Trial Master File archiving of all data management deliverables (e.g., subject CRFs, final query reports, final audit trial reports, interim and final raw data in Clinical Data Acquisition Standards Harmonization (CDASH), data from external sources/transfers, essential data management documents).

• Participation in the identification and registration of project risks related to data management processes, procedures, activities, and deliverables.

• Provide data management oversight support that the Clinical Database Developer is responsible for on data management activities conducted by data management vendors to ensure compliance with the applicable regulations (e.g., 21 CFR Part 11, 21 CFR 312.62(c), 812.140(d), ISO 14155), Good Clinical Data Management Practices (GCDMP), Good Clinical Practices (GCP), and ICH guidelines and to ensure completion, quality, and integrity of data management deliverables meeting the requirements of the project-specific scope of works and agreements, protocols, applicable study data standards (e.g., CDASH, Study Data Tabulation Model (SDTM), Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD), Controlled Terminology, Therapeutic Area), and industry standards.

• Provide data management support that the Clinical Database Developer is responsible for on data management activities and deliverables as the performer for projects to be conducted by ORA Data Management.

• Provide data management support complying with the applicable regulations (e.g., 21 CFR Part 11, 21 CFR 312.62(c), 812.140(d), ISO 14155), GCDMP, GCP, ICH guidelines, study data standards, and industry standards.

• Coordinate and collaborate with the internal ORA data management team on data management timelines of the assigned data management deliverables, tasks, and activities.

• Collaborate and consult with the MRDC’s technical supporting team on the technical problem troubleshooting and system upgrade and maintenance activities of the MRDC in-house’s Clinical Research Data Management System (CRDMS) and its components (e.g., Inform EDC, Central Designer, Central Coding).

• Initiate, log, track, and maintain progress and history tracking of reported technical problems, corresponding resolutions, and their pertinent information for all projects supported by ORA data management team using the MRDC in-house CRDMS.

• Provide technical support related to protocol-specific data management databases to end users for all projects supported by ORA data management team using the MRDC in-house CRDMS.

• Working in an integrated interdisciplinary team dynamic environment on projects governing under varying regulatory agencies depending on the products (e.g., drugs; vaccines, blood, and biologics; medical devices) and regulatory pathways (e.g., Investigational Device Exemption (IDE), Investigational New Drug (IND), New Drug Application (NDA), Biologic License Applications (BLA), Emergency Use Authorization (EUA)) on clinical research and trials in various phases and design.

5 years of related clinical database development experience and must have experience providing clinical research data management oversight support

• Must have hands on experience with InForm GTM

• Must have experience with EDC

• Must have experience with Central Designer and Oracle

• Must have experience providing technical support related to protocol-specific data management databases and end users including - initiate, log, track, and maintain progress and history tracking of reported technical problems, corresponding resolutions, and their pertinent information for all projects

• Experience reviewing SOPs, work instructions, policies, manuals/user guides, and documents related to data collection and management activities and testing and validation documentation of data management systems.

• Experience using the MRDC in-house CRDMS a plus

• Excellent written and oral communication skills., Bachelor’s Degree in Computer Science, or a related discipline, or the equivalent combination of education, professional training, or work experience

Job Location: Frederick, MD (Hybrid). This is a hybrid position and will report onsite 2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.

Compensation: $115,000 - $130,000 base salary, benefits, PTO, etc.

Eligibility/Clearance: Secret Clearance strongly preferred, must be a US Citizen and able to obtain a secret clearance. This position supports a government contract.