Senior Clinical Data Manager

3 days ago

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Logo of Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc.

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

Description

• Responsible for performing end to end Data Management activities. • Leads data management tasks required for phase 1-4 studies. • Represents Data Management at study management team meetings. • Provides mentoring and training to lower-level Data Management staff. • Manages data management activities with CROs or other vendors. • Reviews protocols for appropriate data capture including eCRF design. • Develops or leads the development of the Data Management Plan. • Performs reconciliation of data from external data sources against the clinical database. • Leads database upgrades/migrations.

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. • 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.

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