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Parexel · 6 hours ago

Senior Clinical Database Designer

United States - Baltimore - Maryland

Full-time

Onsite

Senior Level

5+ years exp

Parexel is dedicated to improving the world's health through clinical trials and regulatory solutions. The Senior Clinical Database Designer will lead the setup and execution of clinical data management systems, ensuring compliance and quality in database builds and documentation.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Set-up studies in ClinBase ™

Lead, supervise and/or create, implement and execute user defined procedures specific procedures/pages/templates/screens to build and maintain database set-ups

Create (EDC) clinical data management systems in a standard format as required, including Setup Output Files, Report (e.g. CRFs), where applicable

Lead, supervise and/or create, implement and maintain consistency checks in standard, data capture format for database builds, following and understanding internal and external regulatory requirements

Accountable for first time quality on all deliverables. Participate in the review process of the clinical study protocol, protocol amendments and other study related documents as applicable

Assist in providing technical solutions to internal or external client enquires in terms of EDC study setups and designs

Develop wider knowledge of areas of Clinical Data Base Systems, Electronic Data Capture (EDC), Clinical Trial Management

Ensure adherence to setup timeline and agreement on database finalization

Maintain specific “EDC” study setup and supporting documentation for studies in accordance with SOPs/ other Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams

Maintain technical documentation that is applicable to the Clinical EDC Database system

Participate in the creation of standards, either through tools, libraries or processes, as required for EDC to ensure efficient, effective and optimal processes

Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies

Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial

Provide relevant training and mentorship to staff and project teams as appropriate

Assist project teams in the resolution of problems encountered in the conduct of their daily work

Assist in providing technical solutions to internal or external client enquires

Maintain and expand local and international regulatory knowledge within the clinical industry

Compliant with Study and Sponsor specific training as applicable

Complaint with all Corporate training as applicable

Compliant with mandatory ICH-GCP training and awareness of Health and Safety as applicable

Assist study team, when necessary, on the set-up, review and release processes for ClinBase™

Qualification

EDC systemsClinical data managementClinical research experienceRegulatory complianceTechnical documentationCommunication skillsAttention to detailOrganizational skillsTeamworkProblem solvingLeadership ability

Required

Lead, supervise and/or create, implement and execute user defined procedures specific procedures/pages/templates/screens to build and maintain database set-ups

Create (EDC) clinical data management systems in a standard format as required, including Setup Output Files, Report (e.g. CRFs), where applicable

Accountable for first time quality on all deliverables

Participate in the review process of the clinical study protocol, protocol amendments and other study related documents as applicable

Assist in providing technical solutions to internal or external client enquires in terms of EDC study setups and designs

Develop wider knowledge of areas of Clinical Data Base Systems, Electronic Data Capture (EDC), Clinical Trial Management

Ensure adherence to setup timeline and agreement on database finalization

Maintain specific 'EDC' study setup and supporting documentation for studies in accordance with SOPs/ other Work Instructions to ensure traceability and regulatory compliance