Senior Rave EDC Programmer

Overview

The Senior Rave EDC Programmer provides technical and operational expertise to the project teams and is responsible for ensuring the data collected meets the requirements of the study objectives for the purpose of clinical study reports, publications, and regulatory submissions. 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 always ensure data integrity. S/he is responsible for ensuring study launch, conduct, and closeout are performed according to Iovance’s quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. The assigned clinical trial(s) are immunotherapy studies and very high complexity. Duties include serving as the primary data management liaison with vendors and senior management. This position will manage essential duties and responsibilities as independently as possible. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs for late-stage cancer patients. 

Essential Functions and Responsibilities 

• Builds and maintains clinical databases using Medidata RAVE EDC or Classic RAVE in accordance with standard database structures and /or study specific specifications, including but not limited to developing CRFs, Edit Checks, Derivations, Custom Functions, and integrations with other Medidata modules such as Coder, RTSM and Safety Gateway
• Develops and maintains reports to support data cleaning activities using tools such as Business Objects, QlikView and TIBCO Spotfire
• Generates and maintains documentation for standard procedures, specifications and validation documents
• Ability to work in a fast-paced environment that requires effective multi-tasking and the ability to easily adapt to changing priorities
• Serves as SME for Clinical Programming. Participates in discussions and provides guidance to other team members to implement better solutions
• Possesses and maintains a broad overall knowledge in the field of Clinical Programming and Data Management
• Open to learn new tools as required to support either existing systems or new technologies
• Knowledge of Good Clinical Practices (GCP) related to Data Management programming activities
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel

• Travel to headquarters (San Carlos, CA) may be required on an as needed basis.

Required Education, Skills, and Knowledge

• Bachelor’s degree preferred, or equivalent combination of related education and experience
• 5+ years of experience building clinical databases using Medidata RAVE EDC 
• 8+ years of overall clinical data management or relevant experience
• Experience in programming Rave custom functions using C#
• Ability to deal effectively with internal customers and external vendors at all levels
• Excellent communication and interpersonal skills, both written and verbal

Preferred Education, Skills, and Knowledge

• Experience with programming languages, such as SAS, PL/SQL, Python, R is a plus
• Experience with reporting tools like Business Objects, QlikView or TIBCO SpotFire is a plus
• Experience with CDISC data standards is a plus 

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