Interactive Response Technologies - Project Manager
Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005.
SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Summary
Oversees and coordinates all lRT activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout. Manages the day-to-day IRT project activities including, but not limited to, timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains IRT Programmer on IRT build requirements
Primary Responsibilities
· Lead IRT study setup activities including IRT design and specification (with edit checks) documents and approval and user acceptance testing.
· Allocate and prioritize workloads for multiple projects
· Serve as primary client contact for IRT
· Work with Clinical Data Managers and Statistical Leads with management of timelines and budgets as they pertain to IRT activities
· Work with study team to reconcile IRT data with clinical data and oversees data transfers
· Mentor IRT Programmer on IRT build requirements
· Develop documentation for validation and maintenance of IRT databases for clinical trials using a variety of validated software applications
· Maintains quality control of the data, project deliverables and closeouts
· Adhere to all aspects of the SDC's quality system
· Comply with SDC's data integrity & business ethics requirements
· Develop and maintain SOPs and tools relating to the IRT
· Perform other related duties incidental to the work described herein
· Adherence to all essential systems and processes that are required at SOC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
· Exceptional working knowledge of clinical trials and IRT role in the clinical trials process
· A minimum of 1 year of staff mentoring and leadership experience
· Strong leadership capabilities
· Strong delegation abilities
· Highly effective communication skills, both written and verbal
· Ability to work as a member of a multi-disciplinary team and adapt to changing priorities
· Training and experience in clinical database management
· General knowledge of GCPs and the conduct of clinical trials.
· Understanding of the clinical research process flow and drug development processes.
· Understanding of software development and testing processes.
· Demonstrated proficiency in office productivity applications (e.g., Microsoft Word, PowerPoint, and Excel).
· Excellent organizational skills
· Ability to manage multiple tasks simultaneously and to prioritize tasks effectively.
· Demonstrated ability to focus on project work and efficiently bring projects to completion
· Ability to effectively manage projects, budgets and timelines
· Ability to learn new systems without formal training
Education or Equivalent Experience
Bachelor's degree in engineering, applied or life science and at least two (2) years of experience in management of an IRT system or an Associate's degree in engineering, applied or life science and a minimum of five (5) years of experience in management of an IRT system.
Benefits
Why SDC
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.
• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.
Take a look at how you can join our team!
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