Address
Form of work
SalaryWhat 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
- Experience conducting Cardiovascular trials is preferred but not 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
Position based remote in US or Canada
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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
