Clinical Database Developer
Arena Technical Resources, LLC
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 Clearance strongly 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 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.
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
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.
Job Description:
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.
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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