Senior Clinical Data Manager

Yesterday

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Iovance Biotherapeutics, Inc.

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Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000

Description

• Senior Clinical Data Manager performs end to end Data Management activities. • Participates in planning, leading, and executing Data Management tasks for phase 1-4 studies. • Leads large clinical study or series of related studies with minimal guidance. • Represents Data Management at study management team meetings. • Provides mentoring and training to lower-level Data Management staff. • Manages and monitors data management activities with CROs or other vendors. • Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design. • Leads the development of data edit check specifications and data listings. • Coordinates the design and testing of Electronic Data Capture (EDC) systems. • Reviews and provides feedback on study documents and Statistical analysis plans.

Requirements

• Bachelor's Degree required in the scientific/healthcare field with 9 years of experience. • Master’s degree with 7 years of experience or PhD with 4 years of experience, preferred. • Must have good project management skills and a proven ability to multitask. • Possesses a comprehensive 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. • Possesses strong English language written and verbal communication skills. • Experience in working with oncology studies. • 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.