Clinical Trial Technologies Manager

Clinical Trial Technologies Manager

Requirements

• BS/BA degree in related discipline and a minimum of seven years of related experience; or,
• MS/MA degree in related discipline and a minimum of five years of related experience; or,
• PhD in related discipline and zero or more years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Possess extensive experience in relevant industry/profession.
• Knowledgeable in Good Clinical Practice and FDA regulations.
• Knowledgeable of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred.
• Knowledgeable in Interactive Response Technologies, including design, testing, deployment, user management, and report generation.
• Knowledgeable in Clinical Trial Databases (e.g., EDC, CTMS).
• Previous experience implementing a clinical system (e.g., eCOA, IxRS, ECG, CTMS).
• Apply strong analytical and business communication skills.
• Proficient in Visio, PowerPoint, Excel, Project, and Word.

Responsibilities

• Provide study-level technical oversight and support towards designing, implementing, and maintaining clinical systems (e.g., IxRS, Imaging, eCOA, ECG) and technology to support Exelixis trials.
• Lead development and documentation of study-level business and system requirements with internal stakeholders and technology suppliers.
• Provide study parameters and requirements for RFPs and Scope of Work for evaluation, selection, and startup of technology suppliers.
• Provide study technical parameters and requirements for RFPs and Scope of Work for suppliers evaluation, selection and startup.
• Provide input on clinical systems design specifications, create test cases, and conduct user acceptance test (UAT).
• 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 technology suppliers to develop user requirements that satisfy business requirements.
• Review of technical supplier’s documents (e.g. user requirements).
• Manage suppliers and internal teams for project timelines and associated activities.
• Identify and track study-related technical and system issues to resolution.
• Manage communications and expectations between the study team, internal stakeholders, and the technology supplier.
• Identify metrics and solutions for trend analysis of potential and current issues.
• Collect, track, and analyze supplier performance metrics. Ensure that the supplier provides service and support as outlined in the contract terms and based on agreed-upon performance goals.
• Perform periodic clinical data systems user audits and support records retention management.
• Establish quality standards, investigate compliance in a timely and efficient manner, and implement service improvement plans when required.
• Provide imaging protocol deviation surveillance oversight as well as SOP change management and deviation surveillance.
• Monitor cross-study technical and operational supplier performance and manage escalated issues to resolution.
• Ensure that the Data Protection Act is applied to all subject data and that subject confidentiality is maintained at all times.

Preferred Qualifications

• Experience in Biotech/Pharmaceutical industry preferred.
• Previous experience working in a fast-paced, entrepreneurial environment preferred.
• Experience in imaging or clinical supply or CRO suppliers is preferred.
• Experience in radiographic imaging in a clinical environment preferred.
• Experience in RECIST 1.1 preferred.