Senior Clinical Scientist - Infectious Disease (HIV)
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
