Clinical Database Developer

Clinical Database Developer

Location: Frederick, US

Job ID: ATR 17814

Job Description

Job Title: Clinical Database Developer

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 Clearancestrongly preferred, must be a US

Citizen and able to obtain a secret clearance. This position supports a

government contract.

Job Description:

Seize your opportunity to make a personal impact as aClinical Database

Developersupporting 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 managementactivities 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 orCRFsfor

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 ofData 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.

Requirements:

• 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.

Desired Qualifications:

Education:

• Bachelor’s Degree in Computer Science, or a related discipline, or

the equivalent combination of education, professional training, or

work experience

ATR is an Equal Opportunity Employer (EOE) who will provide equal

employment opportunity to employees and applicants for employment

without regard to race, ethnicity, religion, color, sex, pregnancy,

national origin, age, veteran status, ancestry, sexual orientation,

gender identity or expression, marital status, family structure, genetic

information, or mental or physical disability

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