Senior Clinical Scientist

ICON; Center Square (PA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Senior Clinical Scientist specializing in Infectious Disease (HIV). You will lead studies, oversee design endpoints, and manage Medical Monitoring plans while coordinating with investigators and vendors.

Required are advanced life sciences degrees with multiple years of clinical research, excellent communication, and the ability to travel up to 15%.

Qualifications

• BS/BA in Life Sciences with 7+ years clinical research experience or MS/PhD with 5+ years in life sciences.
• Infectious Disease experience, HIV preferred, and ability to travel up to 15%.
• Excellent written and oral communication skills and regulatory/clinical writing exposure.

Responsibilities

• Lead or support studies; accountable for clinical/scientific execution of protocols.
• Serve as clinical point of contact for scientific issues for internal/external stakeholders.
• Design trial endpoints and lead Medical Monitoring activities including MMP development.
• Coordinate governance, CSRs/CTDs, and collaboration with medical writing.
• Present protocol information at Investigator Meetings and support publications.
• Mentor other Clinical Scientists and support external vendor interactions.

Skills

Excellent communication skills

Excel proficiency

PowerPoint proficiency

Travel up to 15%

Education

BS/BA in Life Sciences with 7+ yrs clinical research experience

MS/PhD in Life Sciences with 5+ years clinical research experience

Tools

Excel

PowerPoint

Job description

Senior Clinical Scientist - Infectious Disease (HIV)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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 SPECTRUM
• 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

What you need to have:

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
• Infectious Disease experience required. HIV experience highly preferred.
• 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