Senior Clinical Data Manager - FSP

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

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​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

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​Required/Preferred Education and Licenses

• ​BA/BS, preferably in the scientific/healthcare field.