Overview
The Clinical Data Management Quality Associate II position provides validation and UAT support for Clinical Data Management activities across studies. This position will lead and coordinate functions for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data. S/he will work within the company’s SOPs, guidelines and standards to ensure data integrity at all times.
Essential Functions and Responsibilities
- Audit potential data management vendors, as appropriate.
- Serve as a technical resource to colleagues; troubleshoot technical problems.
- Assist in the compilation of clinical data for regulatory submissions
- Ability to assist in development of procedures for the CDM Quality group to establish and maintain high quality data throughout the lifecycle. Including collection and cleansing.
- Develop and execute data validation plans to identify and address data inconsistencies, errors, or outliers
- Works to improve clinical data management processes to ensure optimal procedures.
- Perform validation activities to verify the functionality and integrity of the data management systems
- Document data management quality processes and procedures to support regulatory audits
- Communicate data quality issues and concerns to relevant parties, including study investigators and project management.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Strong working knowledge of clinical data management systems (CDMS) and data validation tools
- S. (or equivalent degree) in a scientific or allied health field (or equivalent degree)
- 5+ years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
- Excellent verbal and written communication skills and strong interpersonal skills are required.
- Experience with Electronic Data Capture (EDC) & other data management systems
- Strong understanding of clinical research methodologies and regulatory requirements
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 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.
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 workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.
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.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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