Global Senior Study Site Specialist

Pharmaceutical Research Associates, Inc; Canada; Remote; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Site Manager to oversee site management from feasibility to activation. In this pivotal role, you will act as the primary liaison between the site and study team, ensuring smooth operations throughout the study lifecycle. Your expertise in project management and negotiation will be crucial as you handle contracts and budgets while maintaining a focus on detail and quality. With a commitment to fostering a diverse and inclusive culture, this innovative firm offers competitive salaries and a range of benefits designed to promote well-being and work-life balance. If you're ready to make a meaningful impact in the biopharmaceutical sector, this opportunity is for you.

Benefits

Annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme

Life assurance

Flexible benefits like childcare vouchers

Gym discounts

Travel passes

Health assessments

Qualifications

• 5+ years of experience in the biopharmaceutical or CRO industry.
• Proficiency in Veeva Vault and Microsoft Office applications.

Responsibilities

• Conduct end-to-end site management from feasibility to site activation.
• Oversee contract and budget negotiations for clinical trials.
• Support Ethics Committee and Regulatory Authority submissions.

Skills

Project Management

Negotiation Skills

Detail-oriented

Interpersonal Skills

Problem Solving

Flexibility

Education

Bachelor’s Degree in Business Administration

Bachelor’s Degree in Finance

Bachelor’s Degree in Science

Tools

Veeva Vault

Microsoft Office

Job description

Overview

Under the guidance of the Director of Global Site Management & Central Services, this position is responsible for conducting end-to-end site management from feasibility to site activation. It serves as the primary point of contact for the site and the study team, supporting site feasibility assessments, coordinating site identification at country and regional levels, supporting site qualification, and managing study and site start-up, maintenance, and close-out activities.

Responsibilities

1. Assist in developing in-house model process documents.
2. Serve as an In-House Study Lead, acting as the primary contact for the study team on end-to-end study activities.
3. Lead In-House Study team meetings as appropriate.
4. Participate in In-House Study Management meetings.
5. Utilize tools to track activities and develop reports.
6. Oversee feasibility activities, including negotiation and collection of Confidential Disclosure Agreements and analysis of Feasibility Questionnaires.
7. Oversee site contract and budget negotiations (Confidentiality Agreements, Clinical Trial Agreements, and Ancillary Agreements).
8. Manage essential document collection, tracking, and review.
9. Support the collection of country and site-level intelligence.
10. Assist with Ethics Committee and Regulatory Authority submissions.
11. Support country and site-specific activities as required, such as obtaining import/export licenses and approvals from radiation boards or biobank committees to activate sites.
12. Assist in developing in-house study processes and procedures.

Qualifications

• Bachelor’s Degree in Business Administration, Finance, Science, or a related field.
• Minimum of five years of relevant experience in the biopharmaceutical or CRO industry.
• Global experience in the US and EU.
• Flexibility to adjust to changing priorities.
• Goal-oriented, self-starter with the ability to work independently.
• Proactive in identifying issues and proposing solutions.
• Detail-oriented.
• Ability to manage multiple tasks simultaneously and meet deadlines.
• Proficiency with Veeva Vault and all Microsoft Office applications.
• Good interpersonal skills.
• Comfortable with ambiguity and able to act without having the complete picture.

What ICON Can Offer You

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

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

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

Our Commitment to Inclusion & Belonging

ICON is dedicated to providing an inclusive and accessible environment. We are committed to equal opportunity employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For reasonable accommodations, please visit: https://careers.iconplc.com/reasonable-accommodations

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