Senior Clinical Data Manager

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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

• The Senior Clinical Data Manager is responsible for performing end to end Data Management activities. • Participates as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. • Must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with minimal guidance. • Leads a large clinical study or a 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 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. • Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design. • Performs a thoroughly detailed review of eCRF data requirements and create one if need be. • Interacts with CRAs, programmers, study operations lead and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines. • Leads the development of data edit check specifications and data listings. • Coordinates the design and testing of Electronic Data Capture (EDC) systems according to company processes. • Resolves EDC system issues with team members. • Develops or lead the development of the Data Management Plan for a clinical study. • Reviews and provides feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications. • Provides training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. • Performs reconciliation of data from external data sources against the clinical database. • Performs Serious Adverse Event reconciliation activities according to SOPs and guidelines. • Leads database upgrades/migrations including performing User Acceptance Testing. • Performs database lock and freeze activities per company SOPs. • Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Performs miscellaneous duties as assigned.

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.