Senior Clinical Data Analyst Job at Parexel (Remote)

Job Description

Parexel is currently seeking a Senior Clinical Data Analyst to join us in either UK, South Africa, or Poland, dedicated to a single sponsor. This role will be responsible for performing Data Management activities that support the sponsor's commercial and development projects worldwide. The successful candidate will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase I studies with the sponsor's Healthy Volunteers unit. The Senior Clinical Data Analyst has a broad, fundamental knowledge of the data management process and can perform most required tasks with minimal guidance. Working as a Senior Clinical Data Analyst at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your outside life. This will be a fully remote home-based position. RAVE experience is strongly preferred.

Job Responsibility

Lead a large clinical study or a series of related studies with minimum guidance
Represents Data Management on the CTWG for assigned studies
Provide mentoring and training to lower-level Data Management staff assigned to your studies
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
build effective relationships with CRO / vendor counterparts
Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
Be able to perform a thoroughly detailed review of eCRF data requirements
Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines
Lead the development of data edit check specifications and data listings
Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards
Able to resolve EDC system issues with team members
Develop or lead the development of the Data Management Plan for a clinical study
Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
Perform reconciliation of header data from external data sources against the clinical database
Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
Lead database upgrades/migrations including performing User Acceptance Testing
Maintain study workbooks and data management files
Perform database lock and freeze activities per company SOPs
Participate in regular team meetings and provide input when appropriate
Provide input into the development of data management SOPs, Work Instructions, and process documents
take a leadership role in the development of assigned documents
Contribute to a professional working environment including the application of the sponsor's Code of Business Conduct and Ethics
Assist with the training of new employees and/or contractors

Requirements

Bachelor's Degree required, preferably in the scientific/healthcare field
Proven leadership experience
Good project management skills and a proven ability to multitask
At least five years' or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry
Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors
A high level of Phase I experience is essential
A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Strong English language written and verbal communication skills
Able to travel to meetings or training seminars on occasion
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications
Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable

What we offer

annual performance-based bonus plan
annual salary review
total rewards incentives

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Senior Clinical Data Analyst

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