Senior Clinical Scientist

ICON Strategic Solutions; United States; Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Annual leave Entitlements

Health insurance

Retirement planning offerings

Employee assistance programme

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Clinical Scientist in Infectious Disease (HIV) for a home-based role in the US/Canada. You will lead or support studies, design trials, and oversee medical monitoring while collaborating with cross-functional teams and external stakeholders.

The position requires strong clinical development experience, trial design expertise, and the ability to travel up to 15%. ICON emphasizes sponsor-dedicated support and a global expertise network to advance

Qualifications

• BS/BA in Life Sciences with 7+ years clinical research experience.
• MS/PhD in Life Sciences with 5+ years clinical research experience.
• If no degree in Life Sciences, substantial clinical development experience (>11 years).

Responsibilities

• Lead or support studies with responsibility for clinical/scientific execution.
• Serve as clinical contact for internal/external stakeholders.
• Lead trial design and endpoint development with CD.
• Oversee Medical Monitoring activities and MMP creation.
• Coordinate labs, biospecimens, and imaging specifications.
• Collaborate on CSR planning and CTD/WMAs with medical writing.
• Mentor other clinical scientists and support publications.

Skills

Clinical trial leadership

Medical monitoring

Protocol development

Data review

Communication skills

Travel up to 15%

Education

BS/BA in Life Sciences

MS/PhD in Life Sciences

Clinical development experience (11+ years)

Tools

CTMS

EDC

CRFs

Job description

Clinical Scientist - Infectious Disease (HIV) - Home Based (US/Canada)

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Be Doing

• May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.
• As lead, will be responsible for the following:
• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
• Responsible for trial design and endpoint development in collaboration with CD
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
• Sets up/supports SAC, DMC, adjudication committees
• Protocols/amendments – collaborates with medical writer, participates in governance committee review
• Authors protocol clarification letters
• Contributor to study specific documents (e.g., SMP)
• Reviews/updates informed consent
• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
• Monitors data issues requiring clinical input
• Monitors central lab reports and other external data for safety and critical values
• Prepares scientific slides, attends and presents protocol information at Investigator Meeting
• Scientific lead on Clinical Trial Team (CTT)
• Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system
• Coordinates planning of lab, bio specimens and imaging specifications
• Co- authors newsletters with SM
• Participates in Database lock activities Collaboratively plans CSRs, CTDs/WMAs with medical writing
• Supports publications/presentations as needed
• Reconciles and review all protocol deviation classifications in CTMS
• Assesses and prepares protocol deviation list for CSR
• Collaborates with medical writing to develop trial results communication for investigators
• Provides scientific assessment for Operational Reviews
• Supports SM/MW activities as needed to achieve CTT deliverables.
• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
• May act as mentor to other CSs

Educational Requirements

• BS/BA in Life Sciences with 7+ yrs clinical research experience
• MS/PhD in Life Sciences with 5+ years clinical research experience
• If no degree in Life Sciences, must have significant experience in clinical development (>11 years)

Minimum Years Of Experience

• Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required.
• Medical monitoring experience required
• Oncology experience required
• Excellent Excel and PP skills required
• Excellent written and oral communication skills
• Ability to travel up to 15% (might include international travel)
• To qualify, applicants must be legally authorized to work in the Canada or US, and should not require, now or in the future, sponsorship for employment visa status

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, color, 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 or submit a request here