Clinical Data Manager – FSP
Location
Poland
Posted
1 day ago
Salary
zł165K - zł207.5K / year
Seniority
Senior
Job Description
Clinical Data Manager – FSP
Parexel
• Lead a small clinical study or co-lead a larger study or studies with moderate guidance. • Be able to 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. • 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. • 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. • Participate in regular team meetings and provide input when appropriate. • Provide input into the development of data management SOPs, Work Instructions, and process documents. • Assist with the training of new employees and/or contractors. • Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.
Job Requirements
- Bachelor’s Degree required (master’s preferred), preferably in the scientific/healthcare field.
- At least five 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.
- Detail-oriented with a proven ability to multitask and work independently.
- Excellent time management and organizational skills, with highly developed problem-solving and analytical abilities.
- Strong English language written and verbal communication skills.
- Able to travel to meetings or training seminars on occasion.
Benefits
- Annual performance-based bonus plan
- Annual salary review
- Total rewards incentives
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