Clinical Data Manager II [Contract]

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

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 The Clinical Data Manager II should be able to:

Essential Functions and 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

Required Education, Skills, and Knowledge 

• 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

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of
• 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 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

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

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The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.  

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