Clinical Trial Manager- Cambridge, MA

Pharmaceutical Research Associates, Inc; Boston (MA); On-site; USD 90,000 - 140,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Trial Manager. This pivotal role involves overseeing compliance with regulations while managing relationships with study sites and ensuring data accuracy throughout clinical trials. The ideal candidate will have a strong background in clinical research, as well as 3-5 years of experience in the medical device or pharmaceutical industry. ICON values diversity and offers competitive benefits focused on employee well-being.

Benefits

Various annual leave entitlements

A range of health insurance offerings

Competitive retirement planning offerings

Global Employee Assistance Programme

Life assurance

Flexible country-specific optional benefits

Qualifications

• 3-5 years of experience in execution of clinical research.
• Minimum 3 years of experience in medical device or pharmaceutical industry.
• Profound knowledge of clinical research process legislation.

Responsibilities

• Participates in handling clinical studies in compliance with regulations.
• Tracks study progress and performance against milestones and timelines.
• Acts as a subject matter expert for GCP, ISO, and FDA requirements.

Skills

Knowledge of Good Clinical Practice (GCP)

Data accuracy and study integrity

Regulatory compliance

Education

Bachelor's/ Master's Degree in Life Science

Job description

Overview

As a CLinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Participates in the handling of clinical studies, in compliance to all applicable regulations (like ISO, GCP and FDA) and Philips procedures, working under limited supervision.
• Ensures strict adherence to study protocols, regulatory standards, and Philips
• Processes/Procedures through meticulous execution of site assessment, on site and remote monitoring and training, and close-out visits, proactively addressing deviations and ensuring data accuracy and study integrity.
• Works with study sites and investigators to provide support and guidance on protocol requirements, study procedures, and regulatory expectations.
• Acts as a subject matter expert to provide guidance on GCP, ISO and FDA regulatory requirements for the conduct of research involving human subjects is required in the medical device industry.
• Helps to review project documentation and deliverables for accuracy, completeness, and compliance with established protocols and regulatory requirements and GCP guidelines.
• Enhances study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle and performs data review and verification activities to ensure accuracy and consistency of clinical trial data.
• Nurtures and maintains relationships within the Clinical and Medical functions, as well as crossfunctionally with Clinical Development, Biostatistics and Data Managements, Regulatory, R&D, Quality and HEMAR and other internal partners to achieve project objectives.
• Tracks study progress and performance against milestones, timelines, and budgetary constraints, conducting in-depth analysis of trends and deviations to inform proactive decisionmaking, risk mitigation strategies, and continuous improvement initiatives.
• Resolves queries, issues, and discrepancies related to study conduct, data collection, and regulatory compliance in a timely and effective manner.
• Supports the development of study plans and protocols, integrating regulatory requirements, Good Clinical Practice (GCP) guidelines, and study objectives to ensure robust study design and execution.
• Utilizes clinical trial applications including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with high level of competency.
• Fosters effective collaboration and communication with across cross-functional teams and external collaborators, facilitating problem-solving, decision-making, and alignment on study objectives and priorities throughout the project lifecycle.
• Drafts critical and timely study updates, findings, and recommendations to study leadership and senior management, demonstrating comprehensive understanding and analysis of study progress, challenges, and opportunities.

Qualifications

You are:

• Bachelor's/ Master's Degree in Life Science or equivalent. Experience in MedTech and understanding of Health Care Administration or equivalent.
• 3-5 years of experience in Execution of Clinical Research or equivalent.
• Minimum 3 years of experience in Medical device, pharmaceutical industry, or other regulated environment experience is required, with medical device clinical study experience high preferred.
• Profound knowledge of clinical research process legislation and ICH-GCP guidelines.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.