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Clinical Data Manager II
Iovance Biotherapeutics, Inc.Clinical Data Manager II assisting in end-to-end Data Management activities for Iovance Biotherapeutics cancer therapy. Responsible for data integrity, compliance, and collaboration with multi-disciplinary teams.
About the role
Key responsibilities & impact- Ensure the integrity, accuracy and compliance of clinical trial data
- Assist during a study database in RAVE to include but not limited to:
- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
- Assist with the development of data edit check specifications and data listings
- Perform User Acceptance Testing (UATs) of Electronic Data Capture (EDC) systems according to company processes
- Assist with the review of migration reports to ensure database build accuracy
- Perform reconciliation of data from external data sources against the clinical database
- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Execute data cleaning and discrepancy management to ensure compliance with the protocol
- Track and report study metrics to internal and external stakeholders
- Create or update Data Management Plan (DMP), Data Review Plan (DRP), eCRF Completion Guidelines (eCCGs) and other Data Management required study documents
- Perform database lock and freeze activities per company SOPs
Requirements
What you’ll need- At a minimum, Bachelor's degree required in the scientific or healthcare field
- At least 5 years' experience in Data Management for the pharmaceutical / biotechnology industry, or equivalent experience in an FDA-regulated environment including study lead experience
- Oncology experience is a must
- RAVE database experience is preferable
- Must have good time 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.
- 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.
- Experience in Coding (MedDRA and WHODrug), Site and User Management and Lab Normal Range (LNR) entry in Rave is a plus
- Must be able to work collaboratively in a fast-paced environment.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementUser Acceptance Testing (UAT)data cleaningdiscrepancy managementdata reconciliationeCRF designdata edit check specificationscoding (MedDRA, WHODrug)database lockdatabase freeze
Soft Skills
time managementmultitaskingattention to detailcommunication skillscollaborationability to work independentlyability to work in a teamadaptabilityproblem-solvingstakeholder reporting