We are seeking an experienced Manager, Clinical Monitoring responsible for overseeing the departments team of internal and outsourced/FSP Clinical Research Associates (CRAs). The (Senior) Manager, Clinical Monitoring is the owner for monitoring responsibilities within the department to ensure quality and accuracy of clinical trial data collection and consistency of monitoring in accordance with regulatory requirements.

PRIMARY RESPONSIBILITIES:

• Partner with the Head of Clinical Operations and Study Lead(s) (and as applicable, FSP and/or CROs) to evaluate and project clinical trial resourcing requirements necessary to support each study; and develop/execute a resourcing plan that balances geographical cost of travel and expertise of available resources.
• Conduct and/or facilitate hiring operations inclusive of interviews and Human Resources/Quality Assurance onboarding/offboarding.
• Develop, collate, and conduct comprehensive monitoring-specific onboarding and continued training for CRAs inclusive of therapeutic areas, study, and monitoring skills.
• Evaluate, revise, and/or develop monitoring plans, tools, and trainings for each clinical trial; identify resources to aid CRAs.
• Evaluate, revise, and/or develop Standard Operating Procedures (SOPs), Work Instructions, and Best Practices, as applicable to monitoring responsibilities.
• Develop and track monitoring key performance and quality indicators (KPI/KQI) and summarize/report risks and trends to Study Lead.
• Develop and track trial visit and trip report metrics and summarize/report risks and trends to Study Lead.
• Evaluate CRA performance via ongoing KPI/KQI assessments and monitoring oversight visits.
• Ensure CRA adherence to GCP, Standard Operating Procedures (SOPs), and study protocols.
• Mentor junior CRA staff and/or facilitate mentorship opportunities amongst resources.
• Review and approve monitoring visit reports.
• Co-monitor as required to provide training, assist with timely trial monitoring activities, and identify potential issues and inconsistencies that could signal problems with monitoring performance or site data collection.
• Collaborate with the Study Lead on review of site data quality trends via trip reports and data review, including queries and protocol deviations.
• Collaborate with the Study Lead to guide monitor setup and maintenance of the trial sites; ensuring each site has the appropriate trial materials and documents required for activation and continued study implementation.
• As needed, perform site management activities relative to local study start up and maintenance (i.e., contract/budget negotiations, IRB submissions, ICF reviews)
• As applicable, provide managerial oversight for internal resources.
• Ability to travel up to 40%

MINIMUM QUALIFICATIONS:

• BS degree in relevant field
• ACRP/CCRA or equivalent certification/credentials preferred
• 6-8 years of (CRA) monitoring or CRA oversight experience in the pharma, IVD or CRO industry or equivalent
• 2 years of Lead or Senior CRA experience is required
• Experience with EDC systems
• A thorough understanding of clinical processes, ICH, and associated regulatory guidelines
• Excellent verbal and written communication; organizational and planning skills
• Knowledge of infectious disease or emergency or ICF medicine a plus but not required

COMPENSATION AND CLASSIFICATION:

• Classification: Full-time, exempt
• Benefits: Medical, dental, and vision; 401(k), generous leave and more
• Location: (Hybrid) Sunnyvale, CA
• The base salary range for this position is $140,000 - $164,000 per year which represents the low and high end of the anticipated salary range for this exempt position.
  • Please note that actual offer will vary based on factors including, but not limited to the candidate's geographic location, job-related knowledge, skills, and experience among other factors including internal equity. As such, there is the possibility that the final, agreed-upon base salary may be outside of the lower or upper end of the range. Please also note the compensation range listed is just one component of the company's total rewards package. A bonus and/or long term incentive units may be provided as part of the total compensation package, in addition to the full range of medical, financial and/or other benefits, dependent on the level and position offered.
  • U.S. employees are offered medical, dental and vision insurance, as well as access to HSA, FSA, commuter, LTD, STD and basic life insurance. Employees are eligible to enroll in our company 401k plan and employer match. Employees accrue up to 15 paid vacation days, 7 paid sick days and 10 paid holidays per calendar year. Inflammatix U.S. offices are closed for winter break each year between Christmas and New Years Day and the company offers this time as additional paid time off for U.S. salaried/exempt employees.

Inflammatix requires all employees to be vaccinated against COVID-19 (subject to any legally protected exemptions). For travel, Inflammatix requires compliance with all applicable local and national health and safety guidelines.

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.

Notice to Agencies: Our internal Talent Acquisition Team manages all career opportunities. Agencies and independent recruiters must be approved as a vendor by the Legal and Talent Acquisition teams at Inflammatix before submitting candidates (for any current or future positions) to any employee of Inflammatix. We do not accept unsolicited resumes or profiles from agencies or independent recruiters under any circumstances. Inflammatix will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume or profile. Please do not contact Inflammatix employees directly. Compliance with this request will impact our decision to engage or work with you or your agency and/or representatives in the future.