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:
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.
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