Iovance Biotherapeutics, Inc. · 23 hours ago
Senior Clinical Data Manager
United States
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expIovance Biotherapeutics is a company focused on innovative therapies in the field of oncology. They are seeking a Senior Clinical Data Manager to lead and execute data management tasks for clinical studies, ensuring effective collaboration with multidisciplinary teams and external vendors.
BiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedical
Responsibilities
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
Qualification
Required
Bachelor's Degree or equivalent experience required in the scientific/healthcare field with a minimum of 8 years of experience
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
Preferred
Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable
Company
Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer.
501-1000 employees
H1B Sponsorship
Iovance Biotherapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (11)
2023 (7)
2022 (7)
2021 (2)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.58B2024-02-20Post Ipo Equity· $211M
2023-07-10Post Ipo Equity· $150M
2020-05-27Post Ipo Equity· $603.7M
Leadership Team
Jean-Marc Bellemin
Chief Financial Officer
Cheryl Aranda
Executive Assistant to Chief Medical Officer
Recent News
2025-12-29
2025-12-07
2025-11-11
Company data provided by crunchbase