Category Data Management
ABOUT THIS ROLE
Parexel is currently seeking a Clinical Data Associate II to join us in 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 – IV studies. The Clinical Data Associate II has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance.
Working as a Clinical Data Associate II 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 small clinical study or co-lead a larger study or studies with moderate guidance.
Support several clinical studies with minimal guidance.
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies.
Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
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.
Develop data edit check specifications and run data listings as required.
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 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.
Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries.
Perform reconciliation of header data from external data sources against the clinical database.
Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
Assist in database upgrades/migrations including performing User Acceptance Testing.
Able to maintain study workbooks and data management files.
Perform database lock and freeze activities per company SOPs.
Provide input into the development of data management SOPs, Work Instructions, and process documents.
Here are a few requirements specific to this advertised role.
Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field.
At least two 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.
An 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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