IQVIA

Clinical Project Manager- IVD

IQVIA • $93K — $232K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Minimum of a bachelor's degree in Life Science or relevant expertise in Healthcare
  • 5+ years of relevant experience, including 1+ years in project management
  • Experience with Companion Diagnostic (CDx) studies
  • Knowledge of EU In Vitro Device Regulation (IVDR) submission process
  • Excellent teamwork and collaboration skills

Responsibilities

  • Lead global study team with accountability for quality, budget, and timelines
  • Develop key study documents such as protocols and reports
  • Oversee operational aspects of companion diagnostics studies
  • Ensure compliance with regulations and audit readiness
  • Execute studies through all phases from planning to close-out
  • Track project performance to meet goals within scope and budget
  • Build collaborative relationships with stakeholders and outside partners

Benefits

  • Opportunity to work with Pharma partners on innovative studies
  • Dynamic work environment focused on collaboration and best practices
  • Engagement with cross-functional teams
  • Potential for bonuses and incentive plans
  • Diverse range of health and welfare benefits
Full Job Description
Job Summary

The Project Lead is responsible for ensuring that all studies are designed, planned, executed, monitored, closed out and documented in an appropriate manner within the planned timeframe and cost; ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to all applicable regulatory requirements. Responsible for the timeline and budget planning and execution of studies. Assigns and ensures delivery of specific tasks to/from other members of the study team. Provides oversight to outside support including CROs, consultants and/or medical advisors.

Responsibilities
  • Leading the global study team with full accountability for study deliverables regarding quality, budget, and timelines.
  • Developing key study documents (e.g., Design Validation Plan, protocol, study training materials, study forms and templates, study report).
  • Overseeing planning and operational aspects of companion diagnostics studies sponsored by Pharma partners.
  • Ensuring adherence to regulations, guidelines, and standard operating procedures, and ensuring audit/inspection readiness.
  • Executing sponsored studies for assigned areas of focus through all study phases (planning, start-up, conduct, and close-out).
  • Overseeing projects to ensure completion on-time, within scope, and budget; tracking project performance to analyze the completion of short and long-term goals.
  • Building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners, including CROs.
  • Collaborating across Clinical Operations and other functions to develop and implementing best practices across Clinical Operations.


Requirements
  • Experience with Companion Diagnostic (CDx) studies.
  • Team-oriented with excellent collaboration skills with a cross-functional team.
  • Open-minded to learn new ways of doing things while leveraging previous experience.
  • Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process
  • Minimum of a bachelor's degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field, at least 5years of prior relevant experience including > 1 year's project management experience.
  • Conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or related areas.


The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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