Senior Clinical Scientist/Medical Monitor - Cardio - Home Based (US or Canada)
- Canada, United States
- ICON Strategic Solutions
- Clinical Trial Management
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a Sr Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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
Cardiovascular experience (i.e. atherosclerosis) 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
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
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Career ProgressionContent type
BlogsPublish date
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
Similar jobs at ICON
Salary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Director within the Clinical Pharmacology Group, you will have ultimate responsibility and accountability for clinical pharmacology programs.
Reference
2024-110579
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Senior Clinical Project Manager you will be joining the brightest minds in the industry to transform clinical research.
Reference
2024-113465
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Lead Clinical Oversight Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The primary responsibility of the
Reference
2024-114028
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114098
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
Madrid
Department
Clinical Trial Management
Location
Madrid
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Local Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The LTM is the primary point of contact at a co
Reference
2024-114181
Expiry date
01/01/0001
Author
Ana Guerra GaraetaAuthor
Ana Guerra GaraetaSalary
Location
United Kingdom
Department
Clinical Trial Management
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
UK homebased Clinical Risk Manager (CRM)Are you an experienced Clinical Research or Clinical Project Manager with a flair for innovation, team leadership and engagement and a proactive approach to man
Reference
2024-114193
Expiry date
01/01/0001
Author
Elisabeth TrivicAuthor
Elisabeth Trivic