Full-Time

Project Manager/Senior Human Subject Protection Scientist

Posted on 3/7/2025

Icon

Icon

10,001+ employees

Consulting and development services for pharmaceuticals

No salary listed

Senior

Company Does Not Provide H1B Sponsorship

Frederick, MD, USA

Onsite position at Fort Detrick, MD.

Category
Project Management
Business & Strategy
Requirements
  • Bachelor’s degree required
  • 5+ years of experience in human research protection, IRB protocol review, regulatory compliance, or quality assurance
  • Project management experience, including staff supervision and workflow oversight
  • Strong knowledge of Federal, DoD, DA, and USAMRDC human subjects’ protection and cadaver use regulations, including the Common Rule and HIPAA
  • Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred
  • Experience conducting regulatory reviews, IRB pre-reviews, and compliance assessments
  • Proven ability to develop policies, procedures, and training programs for regulatory compliance
  • Strong leadership, problem-solving, and communication skills, with experience in performance improvement initiatives
Responsibilities
  • Serve as the on-site PM, supervising contract personnel at OHARO and OHRO
  • Maintain a small caseload of protocols to stay current with processes and provide effective guidance
  • Conduct initial administrative reviews of research submissions, ensuring compliance with Federal, DoD, DA, state, host nation, and USAMRDC regulations
  • Identify deficiencies and provide regulatory recommendations
  • Assist in updating policies and guidelines while providing regulatory guidance to investigators and research staff
  • Review and update training materials to reflect the latest human subjects protection and cadaver use regulations
  • Maintain and update protocol tracking systems, ensuring accuracy in automated compliance databases
  • Participate in workflow optimization initiatives, contributing to standard operating procedures (SOPs) and work instructions
Desired Qualifications
  • Master’s preferred
  • Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred

Icon provides consulting, development, and commercialization services to help clients in the pharmaceutical and medical device industries accelerate the creation of products that enhance health and well-being. Their services are designed to streamline the process of bringing drugs and devices to market by focusing on reducing time and costs while improving quality. With a presence in 53 countries, Icon leverages a global network of experts who have experience across various therapeutic areas. This extensive expertise allows them to tailor their solutions to meet the specific needs of their clients, setting them apart from competitors who may not offer the same level of specialized support. The primary goal of Icon is to support the development of life-saving and life-enhancing products efficiently and effectively.

Company Size

10,001+

Company Stage

IPO

Headquarters

Ireland

Founded

1990

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Simplify's Take

What believers are saying

  • Partnership with Mural Health enhances participant experience in clinical trials.
  • Increased use of AI optimizes trial methodologies and patient recruitment.
  • Recognition as a climate leader boosts ICON's appeal to socially conscious clients.

What critics are saying

  • Securities fraud lawsuit may impact investor confidence and financial stability.
  • Emerging CROs with advanced technologies pose competitive threats to ICON.
  • Challenges in optimizing biomarker technologies could hinder neurodegenerative research competitiveness.

What makes Icon unique

  • ICON leverages AI to accelerate biomarker detection in clinical trials.
  • The company focuses on patient-centric technologies like Mural Link for trial management.
  • ICON is recognized for its strong ESG practices, enhancing its industry reputation.

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Benefits

Health Insurance

Paid Vacation

401(k) Retirement Plan

Mental Health Support

Life Insurance

Flexible Work Hours

Company News

Rewbix
Mar 21st, 2025
Legal Turmoil for ICON Public Limited Company (ICLR): A Deep Dive into the Financial Impact of Securities Fraud Lawsuit

ICON Public Limited Company (ICLR), a leading healthcare and pharmaceutical services provider, has been hit by a securities fraud class-action lawsuit.

Rewbix
Mar 16th, 2025
Securities Fraud Class Action Lawsuit Filed Against ICON Public Limited Company (ICLR)

The law firm Kessler Topaz Meltzer & Check, LLP announced on March 16, 2025, that it has filed a securities fraud class action lawsuit against ICON Public Limited Company (ICLR).

PharmiWeb
Mar 4th, 2025
​​Mural Health And Icon Announce Partnership To Enhance Participant And Site Experience In Clinical Trials​

BERWYN, PENNSYLVANIA and DUBLIN, IRELAND, 4 March 2025 - Mural Health Technologies, Inc., a patient-first clinical trial technology company, and ICON plc (NASDAQ: ICLR), a global healthcare intelligence and clinical research organisation, today announce a partnership to utilise the participant management and payments platform, Mural Link. ICON will ​utilise​ Mural Link’s innovative functionality related to clinical trial participant payments, tax management, travel and concierge support, site-participant communication tools, and novel reporting and analytics capabilities. “From our very first conversations with ICON, we were highly impressed by their commitment to patient care and innovation,” said Sam Whitaker, CEO of Mural Health. “This partnership represents a shared vision of removing barriers to trial participation​ and advancing participation financial neutrality​, while eliminating the need for site staff to manage highly manual, error-prone, and time-consuming administrative activities.”

PharmiWeb
Jan 9th, 2025
Biomarker And Trial Optimisation Needed To Drive R&D Progress In Alzheimer’S And Related Disorders – Icon Survey

Dublin, Ireland – 8 January 2024 – ICON plc, (NASDAQ: ICLR) a world-leading clinical research organisation powered by healthcare intelligence, today released the findings of a survey of over 120 biotech and pharma professionals developing treatments for neurodegenerative disorders. The findings indicate that, despite recent successes in developing disease modifying treatments for Alzheimer's, persistent challenges that remain in neurodegenerative clinical trials can be mitigated by underutilised trial methodologies. ICON outlines how these innovations, including increased use of biomarkers and innovative trial designs, can be implemented in its new whitepaper: ‘Early, precise and efficient: The methods and technologies advancing Alzheimer’s and Parkinson’s RD’. Biomarkers are one of the most promising tools to identify potential clinical trial participants early in their disease progression. Encouragingly, nearly all respondents (97%) reported using biomarkers to identify patients and over half (59%) are leveraging AI tools to accelerate biomarker detection. Whilst this uptake is promising, biomarkers are not yet being optimised for full implementation

PharmiWeb
Dec 19th, 2024
Icon Announces Appointment Of Chief Operating Officer

Dublin, Ireland – 18 December 2024 –ICON plc (NASDAQ: ICLR), a world-leading healthcare intelligence and clinical research organisation, today announced the appointment of Barry Balfe as Chief Operating Officer (COO).Barry is a long-tenured ICON employee with over 20 years of service and brings extensive leadership experience and capability to the role of COO. He has held a number of leadership roles across both full service and functional solutions at ICON and has very successfully supported the growth of new and existing customer partnerships. His strong focus and track record on operational excellence, quality & delivery will enable the company to deliver greater value to our customers and further enhance our strategy to become the healthcare intelligence partner of choice in the industry.Barry will continue to report to ICON’s Chief Executive Officer, Steve Cutler.“Barry is a vastly experienced leader and has a very strong reputation across the industry” said Steve Cutler, ICON’s CEO “He has successfully led our largest division over the past number of years, creating and sustaining strategic partnerships with customers that have been key to our growth trajectory as a company. I look forward to working closely with Barry to drive further growth across the organisation, as we create value for our customers in delivering their clinical development programs more efficiently.”“It is a privilege to serve as ICON’s Chief Operating Officer,” said Barry Balfe. “I look forward to working with all of our dedicated colleagues around the world as we continue to drive superior innovation, execution and delivery for customers and for patients.”About ICON plcICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations

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