POSITION SUMMARY:

The Senior Data Manager will be responsible for performing internal and outsourced Data Management activities that support Rigel Pharmaceuticals’ commercial and development projects as assigned. The Senior Clinical Data Manager has fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance. This role will report to the Associate Director, Data Management.

Salary Range:

Premium $165,000 - $180,000 (NY and CA only)

National $150,000 - $165,000 (all other locations)

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Be able to lead a clinical study or a series of related studies with minimal guidance

• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies/outsourced clinical trials; build effective relationships with CRO/vendor counterparts

• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design

• Oversees the development and maintenance of electronic data capture (EDC) systems, including review of eCRF data requirements

• Interact with clinical operations, medical monitors, 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/Data Review Plan for a clinical study

• Perform reconciliation of external data sources against clinical database

• Lead database migrations including performing User Acceptance Testing

• Participate in regular team meetings and provide input when appropriate

• Facilitate internal data review meetings with cross-functional team members

• Generate, process, track, and resolve queries

• Participates in the development and implementation of SOPs, templates, and processes, and other departmental and/or cross-functional activities

KNOWLEDGE AND SKILL REQUIREMENTS:

• BA/BS, preferable in the scientific/healthcare field

• At least five years’ experience in Data Management for the pharmaceutical/biotechnology industry

• Experience and understanding of the Oncology therapeutic area is a requirement

• Experience with web-based EDC, preferable Medidata Rave

• Has good project management skills, verbal and written communication skills, and a proven ability to multitask

• Understands the scope and focus of Phase 1-3 clinical studies, and has a proven ability to perform most of the core Data Management tasks and interact with vendors

• Experience in study start up through database lock

• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug) 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

• Experience with other clinical trial systems, including but not limited to IRT, eTMF, CTMS

• Experience in medical coding in MedDRA and WHO Drug is preferred

• Experience in database programming (ex. Medidata Rave) is preferred

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.

• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.