Clinical Data Manager II [Contract]

Iovance Biotherapeutics

20h•Remote

About The Position

The Clinical Data Manager II will be responsible for assisting the lead data manager in end-to-end Data Management activities. He/she will participate 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 candidate must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with guidance after receiving instructions and / or training.

Requirements

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
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.
Must be able to work collaboratively in a fast-paced environment

Nice To Haves

RAVE database experience is preferable
Experience in Coding (MedDRA and WHODrug), Site and User Management and Lab Normal Range (LNR) entry in Rave is a plus

Responsibilities

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