Clinical Strategy and Solutions Manager (Temp)

Faro Health aims to improve lives by helping life sciences companies answer complex clinical

questions, simply, efficiently and effectively. Our software platform is used to orchestrate complex clinical development with a single source of truth. It brings words, data and teams together, empowering researchers to design more intelligent trials, master complexity and reach milestones faster.

The Clinical Strategy and Solutions Manager is a key stakeholder in the success of our users and supports the enhancement of data-driven features on the Faro Health Platform. In this role, you will utilize your expertise in Clinical Operations to understand and reflect clinical protocols in the Faro Health Platform across a variety of therapeutic areas and study designs. In addition, you will work closely with key customers as a subject matter expert (SME) to drive value and success for our customers. This will require the ability and willingness to get into the details of a variety of protocols, lab manuals, statistical plans, etc., rolling up your sleeves to do highly detailed and precise work. Keen attention to detail and precision for your work and others is critical for this role as you will be responsible for ensuring quality throughout the study modeling and clinical support processes. This includes providing guidance and delegating clinical tasks to junior team members. 

Duties and Responsibilities

• 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

Qualifications

• 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

Skills and Competencies

• Strong organizational, motivational, and leadership skills, promoting a team-based approach
• Strong attention to detail skills and ability to triage and aid in resolution of escalations
• Ability to work independently in a group setting; ability to adjust to changing priorities
• Strong emotional intelligence, interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Strong problem solving skills
• Goal-oriented
• Ability to project and maintain a professional and positive attitude

Salary

• This is a 3 month temporary role with possibility for extension
• Hourly range for this position is $50-$55
• Individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training

Benefits

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