Clinical Strategy and Solutions Manager
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.
Faro is a mission driven company seeking world class people who share our passion for improving drug availability and patient outcomes through better clinical trial design. We pride ourselves on our vibrant, inclusive, and growth mindset oriented culture. Faro offers competitive compensation and benefits, generous vacation and parental leave, and flexible working hours. We are a hybrid workplace where San Diego employees work from their homes as well as in our lovely main headquarters enjoying a gym with classes and (early next year) spa services, outdoor lawn work area, and steeply discounted food hall. Remote employees work from home and visit the main office for group events and in-person collaboration.
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 own the management and ongoing expansion of a high-quality repository of publicly available clinical trial protocols for use in Faro products. You will also own and maintain a library of standardized clinical trial documents, language templates, workshop materials, documentation, and procedures. 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.
Requirements
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 Professional Services 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
- Open to candidates residing in California and Wisconsin.
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
Benefits
Annual salary
The expected salary range for this position is $110,000-$180,000.
Salary listed reflects the base salary only and does not include other elements of total compensation. Individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training
Equity
In addition to this position's salary (listed above), equity will be a major component of the total compensation for this position. We aim to offer higher-than-average equity compensation for a company of our size, and communicate equity amounts at the time of offer issuance.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic)
- Short Term and Long Term Disability
- Paid Time Off (Flexible Vacation Policy; Paid Sick & Public Holidays Observed)
- Continuous Training & Development
- Work from Home, Office or Hybrid
- Peer-to-peer bonus program
- Company/department outings and events
- Stock Option Plan