Study Execution Associate Manager, Patient Centered Endpoints

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

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 Patient Centered Endpoints (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. 

IQVIA’s PCE team delivers 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.

Description

As part of the Study Execution Team (SET), the Study Execution Associate Manager will be responsible for the execution of all operational aspects of the data collection phase of Patient Centered Endpoints (PCE) studies which include a primary research phase.  The Associate Manager will be an integral member of study teams and will be involved in proactive project planning and take ownership of the management of study fielding.  The abilities to multi-task, “think fast on your feet”, creatively problem-solve, and provide accurate information, logistical solutions and support and quality results are keys to success. 

The Study Execution Associate Manager will:

• As part of the project team, will ‘own’ the primary research process from determining feasibility through study closeout.
  • Inform/develop recruitment and overall execution plan, determine feasibility, develop timelines and secure cost estimates with various recruitment partners and/or sites 
  • Inform/develop recruitment materials for Institutional Review Board (IRB) submission
    • Provide input on operational aspects of study protocol
    • Provide input on screening documents, confirmation of diagnosis (COD)
    • Develop patient-facing recruitment materials and ICF
    • Submit and track IRB submissions, and amendments
  • Manage recruitment process
    • Secure recruitment partners (vendors, patient advocacy groups (PAGs), sites) and ensure all logistical pieces are in place: required training, contracting and purchase orders, invoicing, sFTP sites, interviewing platforms, required programming of online materials
    • Provide research materials, determine recruitment processes, provide project briefing, develop recruitment tracker
    • Monitor recruitment process to ensure all subjects meet criteria and requirements are met, coordinate moderator schedules – ‘point person’ for all recruitment partners
    • Manage development and launching of any online recruitment/interviewing materials
    • Provide regular internal/external recruitment/project updates
    • Ensure vendors/sites meet timing and quality standards
    • As needed, screen and schedule KOLS, patients, secure informed consent forms and CODs
    • Coordinate transcriptions
    • Manage payment of honoraria
    • Manage IRB close out, vendor invoicing and other activities related to data collection completion
• Manage project/ vendor related administrative activities
  • Budget tracking: own financial tracking for out-of-pocket costs and billable time
  • Create/request purchase orders
  • Ensure processing of invoices and honoraria
  • Facilitate contracting with PAGs, clinicians, vendors, subcontractors, etc.
  • Ensure new vendors/partners are set up within internal systems
• Work with PCE Quality Assurance team to build processes to ensure all legal and fiduciary requirements are consistently met
  • Receipt of high-quality deliverables from partners
  • Safeguards against unnecessary expenses, inefficiencies and poor delivery 
  • Compliance with legal requirements (fair market value, anonymity, etc.)
  • Liaison between PCE team and HR / Finance / Legal
• Support other project team activities, as required, such as but not limited to: training support, SOP compliance support, project administration and management
• May serve as a line manager for other junior Study Execution Specialists
• May support PCE knowledge management
  • Document maintenance, e.g., bios and CVs, experience database, catalog of instruments developed, publication log, etc.

In addition to the skills and experience above the Study Execution Associate Manager should have:

• Bachelor’s degree or equivalent experience; advanced degree highly preferred
• Fluency in English (spoken and written)

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Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.