Senior Clinical Database Designer

Parexel•Baltimore, MD

12d

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Requirements

Excellent English written and oral communication skills.
Demonstrate ability to learn new systems and function in an evolving technical environment.
Excellent attention to detail.
Ability to work together with a team (including international teams as required) as well as independently.
Work effectively in a quality-focused environment.
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
Business/Operational skills that include customer focus, commitment to quality management and problem solving.
Good business awareness/business development skills (including financial awareness).
Strong leadership ability.
Demonstrate commitment to refine quality processes.
Interest and aptitude for Clinical Research
Computer literacy essential. (e.g. Word, Outlook, PowerPoint and Excel)
Experience of working in a multi-disciplinary team
Experience in supporting counterparts and peers
Understanding of EDC and other eCRF systems
Understanding the importance of data Integrity in the progression of Clinical Research.
Bachelor of Science/Master of Science in a health related, science or equivalent experience.
At least 5 years, clinical and /or research experience in the setup of any EDC preferred.

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™.