Senior Clinical Data Analyst (Home-based) - South Africa, Poland, UK, Hungary, Czechia, France,[...]

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.

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. 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.

Responsibilities

• Lead a large clinical study or a series of related studies with minimum guidance.
• Represent 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 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.
• Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.

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. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well‑being of many patients. You’ll be an influential member of the wider team.

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Summary

Location: South Africa-Bloemfontein-Remote; Hungary-Remote; Czech Republic-Remote; Lithuania-Remote; United Kingdom-London-Gridiron-Remote; Spain-Remote; France-Paris-Remote; Germany-Berlin-Remote; Italy-Remote; Poland-Remote

Type: Full time