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Senior Study Site Specialist

5+ years
Not Disclosed
10 April 24, 2025
Job Description
Job Type: Full Time Education: MBA/BBA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Study Site Specialist

Location: Canada (Remote)

About ICON plc:
ICON plc is a leading global healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment, driving innovation and excellence in clinical development.

Role Summary:
ICON is seeking a Senior Study Site Specialist to join our team. In this role, you will be responsible for managing the end-to-end process of site management, from feasibility to site activation. Serving as the primary point of contact between the site and the study team, you will be integral in coordinating site identification, feasibility assessments, site qualification, and supporting all start-up, maintenance, and close-out activities for clinical trials.

Key Responsibilities:

  • Oversee the end-to-end site management process, serving as the primary point of contact for sites and study teams.

  • Support site feasibility assessments, including the negotiation and collection of Confidential Disclosure Agreements and Feasibility Questionnaires.

  • Oversee site contract and budget negotiations, including Clinical Trial Agreements, Confidentiality Agreements, and Ancillary Agreements.

  • Manage the collection, tracking, and review of essential documents to ensure compliance.

  • Assist in the development of in-house model process documents and study procedures.

  • Support Ethics Committee and Regulatory Authority submissions.

  • Manage country-specific and site-specific activities, such as obtaining necessary licenses and approvals for study activation.

  • Lead In-House Study team meetings and participate in Study Management meetings.

  • Utilize tracking tools to monitor study activities and prepare reports.

Qualifications:

  • Bachelor’s Degree in Business Administration, Finance, Science, or a related field.

  • Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.

  • Global experience, including familiarity with US and EU regulations.

  • Strong organizational and multitasking abilities, with the ability to prioritize effectively.

  • Proactive problem-solver with the ability to identify issues and propose solutions.

  • Detail-oriented with excellent interpersonal skills.

  • Proficient in Veeva Vault and Microsoft Office applications.

  • Ability to manage ambiguous situations and make decisions based on available information.

Work Arrangement:

  • Remote position with flexibility.

Compensation & Benefits:

  • Competitive salary based on experience and qualifications.

  • Comprehensive health insurance options tailored to support you and your family.

  • Retirement planning tools and options for long-term financial stability.

  • Global Employee Assistance Programme (TELUS Health), offering 24/7 access to mental, emotional, and physical well-being services.

  • Life assurance and flexible, country-specific benefits such as:

    • Childcare vouchers

    • Bike-to-work schemes

    • Discounted gym memberships

    • Health assessments

    • Subsidized public transport

Diversity & Inclusion:
ICON is committed to providing an inclusive and accessible environment for all candidates. We ensure equal employment opportunities regardless of race, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.


 

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