Clinical Trial Manager- Cambridge, MA

PRA HEALTH SCIENCES; Boston (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

PRA Health Sciences is seeking a Clinical Trial Manager to oversee clinical studies while ensuring compliance with industry regulations. The ideal candidate will have a strong background in clinical research, especially in medical devices, and will be responsible for managing study protocols, data integrity, and communication with study sites. If you possess a degree in Life Sciences and relevant experience, we invite you to apply and join our diverse and dynamic team.

Benefits

Annual leave entitlements

Health insurance options

Retirement planning

Global Employee Assistance Programme

Flexible benefits

Qualifications

• 3-5 years of experience in Clinical Research execution.
• Experience in medical device or regulated environments.
• Knowledge of clinical research legislation and ICH-GCP guidelines.

Responsibilities

• Handle clinical studies under regulations and company procedures.
• Ensure adherence to study protocols and regulatory standards.
• Collaborate with study sites for protocol guidance.

Skills

Compliance

Data Accuracy

GCP Knowledge

Protocol Management

Education

Bachelor's or Master's Degree in Life Sciences

Tools

EDC

eTMF

CTMS

Job description

Overview

As a Clinical Trial Manager, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Participate in handling clinical studies in compliance with all applicable regulations (such as ISO, GCP, FDA) and company procedures, working under limited supervision.
• Ensure strict adherence to study protocols, regulatory standards, and company policies.
• Execute processes/procedures meticulously, including site assessment, monitoring, training, and study close-out visits, proactively addressing deviations to ensure data accuracy and study integrity.
• Collaborate with study sites and investigators to provide support and guidance on protocol requirements, procedures, and regulatory expectations.
• Serve as a subject matter expert on GCP, ISO, and FDA regulatory requirements relevant to research involving human subjects in the medical device industry.
• Review project documentation and deliverables for accuracy, completeness, and compliance with protocols and regulatory standards.
• Optimize study procedures and processes to enhance efficiency and data quality throughout the clinical research lifecycle; perform data review activities for accuracy and consistency.
• Maintain relationships within Clinical, Medical, and cross-functional teams to achieve project objectives.
• Track study progress against milestones, timelines, and budgets; analyze trends and deviations for proactive decision-making and risk mitigation.
• Resolve queries and discrepancies related to study conduct, data collection, and compliance in a timely manner.
• Assist in developing study plans and protocols, ensuring regulatory compliance and robust study design.
• Utilize clinical trial applications such as EDC, eTMF, and CTMS proficiently.
• Foster effective communication and collaboration across teams and external partners.
• Draft study updates, findings, and recommendations for leadership, demonstrating comprehensive understanding of study progress and challenges.

Qualifications

You are:

• Holding a Bachelor's or Master's Degree in Life Sciences or equivalent, with experience in MedTech or Healthcare Administration.
• Having 3-5 years of experience in Clinical Research execution or equivalent.
• Possessing at least 3 years of experience in the medical device, pharmaceutical industry, or a regulated environment, with preferred experience in medical device clinical studies.
• Knowledgeable about clinical research legislation and ICH-GCP guidelines.

What ICON can offer you: Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Alongside a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Learn more about working at ICON: https://careers.iconplc.com/benefits

ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal employment opportunities and encourage applicants to request accommodations if needed. For more information, visit: https://careers.iconplc.com/reasonable-accommodations

If you're interested but unsure if you meet all requirements, we encourage you to apply. You might be exactly what we're looking for!