Engage with customer Clinical Scientists, Clinical Operations, Data Management, Biostatisticians, Medical Writers, and Project/Program Managers through participation as a CSS representative in study team meetings to understand key components of their clinical study and support them in successful use of the Faro Health Platform
Conduct modeling of studies in the Faro Study Designer for customers, sales demos and delegate and provide guidance of study modeling and other clinical tasks to junior team members
Own the management and ongoing expansion of a high-quality public study library
Work closely with customer users to provide instruction on clinical application of the study designer and explanation of steps taken to accomplish a design in the Faro Health Platform, with the Product Experience team
Support customer relationships while working closely with Customer Strategy from implementation through deployment and beyond to ensure customer success and promote adoption
Work closely with Clinical Data Solutions to provide feedback and support with maintenance of the assessments/ measurements library
Work closely with Product Management to provide user feedback for feature optimization
Contribute to feature development and evaluation through research and modeling of clinical trials in the Faro platform
Work closely with Product Experience to provide clinical expertise for the development of training materials
Ability to travel up to 50% to customer sites and to the office for team meetings, as needed

Requirements

Bachelor’s degree required, preferably in physical or life science or statistics discipline
5-7+ years of Clinical Operations work experience at a sponsor company in pharmaceutical clinical trials preferred. Experience as a Clinical Research Associate a plus
Oncology experience a plus
Strong knowledge of clinical trials and drug development processes
Ability to read and comprehend complex clinical trial protocols and designs
Familiarity with clinical trial technologies (e.g., EDC, IRT, CTMS, ePRO, eCOA, eConsent, TMF)
Knowledge of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA, GDPR)
Understanding of 21 CFR Part 11 compliance requirements and software development life cycle preferred
Ability to understand and communicate architectural requirements, preferences, and limitations preferred
Excellent team player with demonstrated track record of success in a cross-functional team environment; consistent commitment to delivering on team goals with a sense of shared urgency
Ability to work up to 40 hours per week during the core hours of 8am to 5pm Eastern Time
Open to candidates in the following states ONLY: New York, Massachusetts, North Carolina

Benefits

Retirement Plan (401k)
Flexible work hours
Hybrid work environment
Office Gym Access
Employee Restaurant Discounts

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical operationsclinical trialsdrug development processesstudy modelingclinical trial protocolsregulatory requirementsinformation governance frameworks21 CFR Part 11 compliancesoftware development life cycledata management

Soft skills

team playercross-functional collaborationcommunicationcustomer relationship managementinstructional skillsguidancefeedback provisionproblem-solvingadaptabilitysense of urgency