Note: The job is a remote job and is open to candidates in USA. Parexel is currently seeking a Clinical Data Manager to join us in either 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, participating as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase I – IV studies.
Responsibilities
- Lead a small clinical study or a 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
Skills
- Bachelor's Degree required, 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
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications
- Master's degree preferred, preferably in the scientific/healthcare field
- 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
Benefits
- Participation in Parexel’s annual performance-based bonus plan
- Annual salary review
- Total rewards incentives
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