Senior Clinical Data Manager - FSP
Parexel is hiring a Senior Clinical Data Manager in Mexico or Argentina.
The Senior Clinical Data Manager will be responsible for performing Data Management activities that support client’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.
Essential Functions
Be able to lead a large clinical study or a series of related studies with minimal guidance
Represents Data Management on the CTWG for assigned studies
Provide mentoring and training to lower level Data Management staff assigned to his/her 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
May 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
Be 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; take a leadership role in the development of assigned documents
Contribute to a professional working environment including the application of client’s Code of Business Conduct and Ethics
Assist with the training of new employees and/or contractors
Required Knowledge, Skills, and Abilities
At least 8 years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
Has good project management skills and a proven ability to multitask
Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, 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.
Possesses strong English language written and verbal communication skills.
Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are preferred.
Able to travel to off-site meetings or training seminars as needed.
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
Required/Preferred Education and Licenses
BA/BS, preferably in the scientific/healthcare field.
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