Senior Clinical Data Manager @Iovance

[Hiring] Senior Clinical Data Manager @Iovance

Mar 18, 2025 - Iovance is hiring a remote Senior Clinical Data Manager. 💸 Salary: unspecified. 📍Location: USA.

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Role 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. The Senior Clinical Data Manager 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

Qualifications

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

Requirements

Must be able to remain in a stationary position standing or sitting for prolonged periods of time
Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading
This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers
Must be able to communicate with others to exchange information

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Senior Clinical Data Manager @Iovance

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Salary 💸 unspecified	Remote Location USA
Job Type full-time	Posted Mar 18, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Senior Clinical Data Manager @Iovance

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