Iovance Biotherapeutics is hiring a Senior Clinical Data Manager

Iovance Biotherapeutics is seeking a Senior Clinical Data Manager to perform end-to-end Data Management activities for our clinical programs. In this role, you will be an active member of a multi-disciplinary team, responsible for planning, leading, and executing the Data Management tasks required for phase 1-4 clinical studies.

What You'll Do

• Lead a large clinical study or a series of related studies with minimal guidance.
• Represent Data Management at study management team meetings.
• Provide mentoring and training to lower-level Data Management staff.
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies.
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Perform detailed review of eCRF data requirements and create them as needed.
• Interact with CRAs, programmers, study operations lead, and statisticians to design eCRFs and create annotated eCRFs and completion guidelines.
• Lead the development of data edit check specifications and data listings.
• Coordinate the design and testing of Electronic Data Capture (EDC) systems.
• Resolve EDC system issues with team members.
• Develop or lead the development of the Data Management Plan for a clinical study.
• Review and provide feedback on other study documents like statistical analysis plans and vendor specifications.
• Provide training on the EDC system and eCRF Completion Guidelines at Investigator Meetings and to internal/external team members.
• Perform reconciliation of data from external data sources against the clinical database.
• Perform Serious Adverse Event reconciliation activities according to SOPs.
• Lead database upgrades/migrations including performing User Acceptance Testing.
• Perform database lock and freeze activities per company SOPs.
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

What We're Looking For

• Bachelor's Degree or equivalent experience required in the scientific/healthcare field with a minimum of 8 years of relevant experience.
• Strong project management skills and a proven ability to multitask.
• Comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries).
• Excellent attention to detail and ability to work individually, within a multi-disciplinary team, and with external partners.
• Strong English language written and verbal communication skills.
• Experience in working with oncology studies.
• Ability to travel to off-site meetings or training seminars as needed.
• Solid computer system and technical skills with a strong ability to learn multiple computer applications.

Nice to Have

• Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems.

Technical Stack

• Electronic Data Capture (EDC) systems

Work Mode

This is a remote position.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.