Associate Manager, Instrument Svcs, PCE
IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Endpoints (PCE) team leads the industry in breadth and depth of Clinical Outcomes Assessment (COA) and Patient Reported Outcomes (PRO) knowledge. Our diverse team of experts works together to develop, execute, and validate psychometric instruments that capture the patient experience with their treatment or disease, analyze and interpret outcomes, and translate the information to advance the initiatives of life science companies.
The IQVIA PCE team is a specialized and dedicated group of experienced industry professionals who focus on understanding the patient experience and ensuring that scientific rigor required to meet regulatory expectations is incorporated into our methodology and processes. We deliver scientific and technology enabled solutions to biopharma drug development and real-world evidence teams, which are based on insights obtained directly from patients. Our services provide differentiation that helps increase the value of an asset, more accurately measures that value, and maximizes market access and adoption. Our PCE solutions support clinical development and real-world evidence requirements and span the development and commercial lifecycle, starting with early strategy development through results interpretation and dissemination.
Role & Responsibilities
The IQVIA Patient Centered Endpoints group has an opportunity for an Instrument Services Associate Manager to join the team to support Instrument Licensing activities. In this role you will be responsible for licensing Clinical Outcome Assessments (COAs) from their copyright holder or designated distributor for use in clinical trials, real-world studies, or other patient-focused use cases. The role also requires managing development of new translations of COAs by contracting with and overseeing qualified third-party translation vendors. The world of data gathering for instruments is diverse and evolving quickly, so you'll need to ensure you are proactively expanding your knowledge of this important sector focused on capturing the patient’s voice.
Specifically, your role will include:
• Oversight and management of the operational aspects of COA licensing activities and programs from study initiation through to closeout including partnering with study project managers, setting up of vendors within IQVIA systems, facilitating legal reviews/approvals, and ultimately ensuring quality deliverables are on time and within budget.
• Creating, tracking and reporting on COA licensing project support timelines.
• Financial reporting on the COA licensing projects including tracking deliverables and invoicing.
• Monitoring, managing, and communicating expectations and activities related to COA licensing to cross-functional project teams.
• Coordinating with other project resources within and outside the organization.
• Negotiating COA licensing costs and contracts.
• Leading problem solving and resolution efforts.
• Developing and maintaining internal databases of COA licensing requests and project plans.
• Archiving fully executed license agreements and other relevant documentation.
• Maintaining project management information and tracking systems.
• Participating in proposal development and sales/proposal presentations for COA licensing.
• Identifying and requesting scientific support and associated budget for COA licensing and related questions.
• Identification of needs and gaps and creation, support, and development of processes around COA licensing activities for internal team members (from RWAS or RDS).
• Managing COA licensing project budgets and approval of invoices (if applicable).
• Assisting in the creation of a license cost database for project proposals budgeting purposes.
• Implementing continuous improvement activities for assigned COA licensing projects.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 4+ years’ work experience in any of the following functions: clinical research, medical affairs, vendor management, or other related scientific roles
• 2+ years’ work experience in a Project Management, Consulting, or other similar client facing role
- Experience as CRA would be welcomed
• Excellent communication, presentation and interpersonal skills including the ability to communicate effectively with both technical and non-technical audiences.
• Fluency in English (spoken and written).
• Bachelor's degree or equivalent in life sciences, other sciences, or related disciplines.
• Results and detail-oriented approach to work delivery and output and excellent problem-solving skills.
• Excellent planning, time management and prioritization skills.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Ability to think and develop initiatives independently in alignment with the expectations of usual Project Management approaches.
• Sound judgement and ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Strong software and computer skills, including MS Office applications.
• Solid understanding of the pharmaceutical industry and drug development process
• Familiarity with IQVIA business units / functions and ability to navigate the organization effectively is a plus
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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