IQVIA

Post Trial Access Manager

IQVIA • $93K — $232K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • BS/BA or equivalent experience required
  • 2+ years leading global post-trial access (PTA) programs
  • Understanding of regulatory frameworks for investigational products
  • Experience managing multi-regional programs with minimal supervision
  • Strong project management skills in clinical environments
  • Effective collaboration and stakeholder influence abilities
  • Experience in process automation or Lean/Six Sigma is a plus

Responsibilities

  • Develop and manage timelines and budgets for PTA programs
  • Ensure compliance with regulatory requirements and company policies
  • Lead cross-functional teams for PTA program execution
  • Finalize core program documents related to investigational access
  • Drive decision-making on regulatory mechanisms and safety reporting
  • Manage investigational product access requests and vendor contracts
  • Monitor program performance and implement quality checks

Benefits

  • Opportunities for professional development and advancement
  • Collaborative global team environment
  • Flexible working arrangements
  • Potential for work in a dynamic and evolving clinical field
  • Support for further education in subject matter expertise
Full Job Description
Post-Trial Access Manager, Continued Access is accountable for the execution of multiple global PTA programs, of mild and moderate complexity, with minimal supervision.

PTA here refers to the provision of investigational product for the intent of treatment, in a non-trial setting and under the care of a physician, following participation in a trial. PTA by this definition is governed by local laws and regulations and may be provided by established regulatory mechanisms such as early access, named patient programs, and other pre-approval access and managed access programs.

Summary of the Essential Functions of the Job
  • Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
  • Ensure compliance with regulatory requirements and company Policies/SOPs
  • Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
  • Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
  • Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
  • Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed
  • Ensure alignment across PTA program decisions, documentation, plans, and implementation
  • Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
  • Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing
  • Manage vendor contracting and deliverables in support of PTA/continued access program execution
  • Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs
  • Monitor quality, KPIs, and program performance; identify issues and escalate as needed
  • Communicate PTA program status, risks, and updates to stakeholders
  • Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices
  • Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs
  • Support other PTA/continued access activities and programs, as assigned


Minimum Requirements
  • BS/BA (or equivalent experience)
  • Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered
  • General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research
  • Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision
  • Proven experience collaborating effectively; influencing stakeholders across functions and levels
  • Evidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environments
  • Successful history of working independently in a global environment
  • Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.


Additional Attributes Required:
  • Ability and enthusiasm to thrive in a dynamic and evolving clinical development and investigational product access environment
  • Demonstrates a proactive, detail-oriented, critical-thinking, problem-solving, and collaborative approach
  • Interest and continual advancement toward subject matter expertise in PTA space
  • Experience and interest in the Essential Functions listed, particularly those related to continued access for patients receiving investigational therapies


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.

Keep Up to Date

Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at IQVIA

More Pharmaceuticals & Biotech Jobs

Find similar Post Trial Access Manager jobs:

NationwideDurham, NC