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.