ICON is looking for a Senior Clinical Scientist for a fully remote position in the United States or Canada. Please apply if you are working for a Clinical Research Organization, Pharmaceutical Company or Biotech Company and have been in charge of writing the Medical Monitoring Plan (MMP) and managing the medical monitoring team as well as worked on Oncology trials.
Only those who have been in charge of writing the Medical Monitoring Plan (MMP) and managing the medical monitoring team as well as worked on Oncology trials will be considered for this position.
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
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 conducted Oncology trials is 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
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