Sr. Clinical Data Management IxRS/Imaging Can be in either KOP or Alameda This role provides oversight of technology vendors. Needs to have Imaging Vendor experience. SUMMARY/JOB PURPOSE: ** This position is a Data Management role overseeing oncology Imaging Vendors. This is an onsite role to be located in Alameda, CA or King of Prussia PA. The Senior Clinical Trial Technology Manager works independently and cross-functionally with internal stakeholders (Clinical Operations, Data Management, Biometrics, Clinical Supply, QA, Strategic Sourcing and Procurement, Clinical Programming, Clinical Development, and Clinical Science) to support the implementation and maintenance of IxRS systems and other Clinical Technology suppliers to support client clinical trials. This role provides program-level oversight to Clinical Technology suppliers. This role will conduct training on standards, processes, and metrics for the consistent conduct of client trials. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Lead development and documentation of study-level business and system requirements with internal stakeholders and technology suppliers. · Lead the governance and oversight of IxRS, Imaging, ECG, eCOA, and other Clinical Technology suppliers. · Provide study-level technical oversight and support towards designing, implementing, and maintaining the IxRS to support client trials. · Provide study parameters and requirements for RFPs and Scope of Work for evaluation, selection, and startup of technology suppliers · Represent Clinical Trial Technologies group in study team meetings, data working groups, and project workstreams. · Act as Lead Clinical Trial Technologies stakeholder when implementing, maintaining, and closing out various clinical systems. · Manage clinical technology suppliers to develop user requirements that satisfied business requirements. · Manage supplier and internal teams for timelines and associated activities · Identify and track study-related technical and escalated issues to resolution. · Manage communications and expectations between the study team, internal stakeholders, and clinical technology suppliers. · Provide input to IxRS design and specifications and reviewer of IxRS supplier’s documents (e.g., user requirements). · Create test plans for user acceptance test (UAT) and conduct UAT for IxRS and eCOA · Work to identify metrics and solutions for trend analysis of potential and current issues. · Collect, track, and analyze supplier performance metrics. Ensure Clinical Technology suppliers provide service and support as outlined in contract terms and based on agreed-upon performance goals. · Provide imaging protocol deviation surveillance oversight as well as SOP change management and deviation surveillance. · Perform periodic clinical data systems user audits. · Support records retention management. SUPERVISORY RESPONSIBILITIES: No direct reports. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: · BS/BA degree in related discipline and a minimum of nine years of related experience; or, · MS/MA degree in related discipline and a minimum of seven years of related experience; or, · PhD in related discipline and a minimum of two years of related experience; or, · Equivalent combination of education and experience. · May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: · Experience in biotech/pharmaceutical industry is preferred. · Previous experience working in a fast-paced, entrepreneurial environment is preferred. · Experience in clinical operations, supplier management, and cross-functional team leadership is preferred. · Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, PowerPoint). · Experience in imaging or clinical supply or CRO experience is preferred. · Experience in radiographic imaging in a clinical environment preferred. · Experience in RECIST 1.1 preferred. Knowledge/Skills: · Has extensive experience in relevant industry/profession. · Well-versed and Knowledgeable in Good Clinical Practice and FDA regulations. · Well-versed and Knowledgeable of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred. · Use broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways. · Experienced in Interactive Response Technologies, including design, testing, deployment, user management, and report generation. · Experienced in Clinical Trial Databases (e.g., EDC, CTMS). · Previous experience implementing a clinical system. · Develop technical and/or business solutions to complex problems. · Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results. · Perform a variety of complicated tasks with a wide degree of creativity and latitude. · Possess a complete understanding and wide application of technical principles, theories, concepts, and techniques. · Possess a good general knowledge of other related disciplines. · Apply strong analytical and business communication skills. JOB COMPLEXITY: · Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. · Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results. · Creates formal networks involving coordination among groups. System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.