Study Management Associate Jobs in Massachusetts

Clinical Trial Management & Central Trial Oversight (FSP Model)

Home Based Remote Role - East Coast

Role Overview

IQVIA is seeking an accomplished Senior Project Lead / Associate Director, Clinical Trial Management to provide centralized, global clinical trial oversight within our Functional Service Provider (FSP) model. This role partners closely with a Global Trial Leadership and cross-functional stakeholders to ensure the successful planning, execution, and delivery of complex clinical trials across regions and vendors.

You will lead Study Management Teams (SMTs), oversee country and site-facing activities, and ensure trials are conducted with the highest standards of quality, compliance, and inspection readiness-from start-up through close-out. This role is ideal for a senior clinical operations professional who thrives in a matrixed, global environment and is ready to influence strategy, mentor teams, and drive operational excellence.

Key Responsibilities

Global & Regional Trial Leadership

• Lead and coordinate global and regional clinical trial management activities for internally managed and outsourced studies.
• Serve as a core member of the Trial Team, partnering with Global Leadership to deliver operational strategy and execution.
• Act as primary point of contact for country, regional, and functional stakeholders within Clinical Development Operations.
• Function as backup or first point of contact in the absence of the Global Leadership.

Central Trial Oversight & Execution

• Drive trial delivery across the full lifecycle: feasibility, site selection, start-up, execution, and close-out.
• Ensure milestones, timelines, and deliverables are met and transparently communicated.
• Maintain real-time trial oversight through dashboards, reports, and issue tracking.
• Act as the central subject matter expert for assigned protocols.

Vendor & Partner Management

• Provide oversight of CROs and global vendors supporting site-facing activities, including:
  • IWRS/IVRS
  • Central Laboratory
  • ePRO/eCOA
  • Imaging
  • Translation and printing
  • Ancillary supplies and investigator meetings
• Review and approve vendor deliverables, invoices, and spend.
• Ensure vendor performance aligns with trial plans, budgets, and quality expectations.

Quality, Compliance & Inspection Readiness

• Ensure continuous inspection readiness in accordance with ICH-GCP, applicable regulations, and sponsor SOPs.
• Lead or contribute to CAPA development and resolution.
• Support Health Authority inspections, internal audits, and quality reviews.
• Partner with Quality & Compliance stakeholders to ensure effective oversight.

Enrollment, Feasibility & Risk Management

• Lead feasibility activities and provide data-driven recommendations.
• Establish and track regional enrollment commitments, ensuring alignment with projections.
• Ensure robust recruitment and contingency plans are in place.
• Proactively identify risks, escalate issues, and drive resolution.

Documentation, Systems & Trial Deliverables

• Oversee trial documentation, filing, archiving, and retention.
• Create, review, and maintain trial-specific documents, including:
  • Monitoring Guidelines
  • Informed Consent Forms
  • IMP and blinding documentation
  • Feasibility and site selection materials
• Support HA/EC/IRB submissions with required central documents.
• Coordinate data cleaning activities to support timely database lock.

Leadership, Mentorship & Continuous Improvement

• Lead teams across projects or programs.
• Provide coaching and mentoring to less experienced team members.
• Lead or participate in special initiatives, task forces, and process improvement efforts.
• Contribute innovative ideas to enhance operational efficiency and quality across the FSP partnership.

Level Differentiation

(Base Level)

• Independently manages complex trials with limited oversight.
• Demonstrates strong operational leadership and stakeholder management.
• Owns central trial oversight activities and delivers consistent, high-quality results.

(Advanced Level)

• Leads program-level or high-impact trials with increased complexity.
• Manages and mentors multiple team members across insourced and outsourced studies.
• Serves as a Therapeutic Area Expert or Functional Champion, influencing strategy and best practices.
• Proactively identifies and resolves budget, resourcing, and operational risks.

Qualifications & Experience

Education

• Bachelor's degree (or equivalent) in Life Sciences (e.g., Biology, Chemistry, Nursing, Pharmacy).

Experience

• Base:
  • 6+ years of clinical trial management experience in pharma and/or CRO environments.

• Advanced:
  • 8+ years of clinical trial management experience, including leadership of complex global studies.
• Proven experience managing trials from start-up through database lock and close-out.
• Experience coordinating global, virtual teams in a large matrix environment for 2-3+ years.
• Therapeutic area experience required.

Technical & Professional Skills

• Deep knowledge of ICH-GCP, regulatory requirements, and clinical operations best practices.
• Strong project management, planning, and risk mitigation skills.
• Demonstrated ability to manage country and vendor budgets, including OOPs and cost drivers.
• Experience with CTMS, TMF systems, and Microsoft applications.
• Monitoring experience preferred (or equivalent central monitoring/data management experience).
• Strong analytical, decision-making, and communication skills.
• Fluent in English; local language proficiency as required.
• Willingness to travel as needed.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.