Senior Clinical Data Analyst (Home-based) - South Africa, Poland or UK - FSP

Senior Clinical Data Analyst (Home-based) - South Africa, Poland or UK - FSP

Join to apply for the Senior Clinical Data Analyst (Home-based) - South Africa, Poland or UK - FSP role at Parexel

Parexel is currently seeking a Senior Clinical Data Analyst to join us in either South Africa, Poland or the UK, 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 – IV studies.

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.

Responsibilities

• 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

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers.

Parexel is an equal opportunities employer and welcomes applications from all sections of the community. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

#J-18808-Ljbffr