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Senior Manager, Clinical Site Operations

South San Francisco, California, United States,

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   

These values are the foundation of our work, empowering us to make a real difference, every day.  

 

Position Title: Manager, Clinical Site Operations

Department: Development- Clinical Operations

Reports To: Sr Director, Development Operations

 

Job Overview

Kardigan is looking for a dedicated and experienced Manager or Senior Manager, Clinical Site Operations to be a leader on a given study/program and be  responsible for the oversight and management of study execution activities at our clinical investigative sites. This includes oversight and management of Clinical Research Organizations (CROs), Clinical Research Associates (CRAs) / monitors and Investigator Sites. This role will ensure ongoing inspection readiness, data integrity, overall data quality and patient centricity according to and in compliance with applicable SOPs, ICH Guidelines, and Good Clinical Practices (GCP).

Essential Duties and Responsibilities

  • Leads and manages the Clinical Site Operations team on a given study or program. CSO is responsible for the oversight of all CRO work to ensure:
  • Site feasibility and selection are strategic and meet the overarching needs of the protocol
  • Appropriate training of the clinical team and investigators
  • Timely start-up and recruitment goals are met
  • Site payments are completed in a timely manner
  • Understands the clinical trial data flow and schedule of trial procedures to be able to provide site support and troubleshooting
  • Leads the development of study specific and site recruitment plans
  • Carries out site engagement plans at the global and regional level
  • Provides guidance to the team as needed for troubleshooting issues related to site startup, protocol execution or data collection
  • Oversees study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, data query resolution and protocol deviations
  • Proactively identify, prevent, and mitigate site-specific study-related risks
  • Performs regular reviews of data entry, sample tracking and data cleanliness; review safety data to ensure any issues are addressed in a timely manner
  • Utilizes CRO systems to review Monitoring Visit Reports, monitoring visit scheduling, monitoring metrics, protocol deviations, issues, and action items to ensure data quality
  • Occasionally perform site monitoring visits, co-monitoring or monitoring oversight visits to assess quality and compliance by site and site monitors
  • Conduct site visits to foster site relationships, address poor performance, increase site interaction and enrollment, and further ensure adequate oversight of study execution
  • Serves as a direct sponsor contact for sites
  • Review and assess site performance; generate and track key performance indicators (KPIs)
  • Evaluate the quality and integrity of site practices – escalating quality issues as appropriate
  • Participate in the maintenance of the Trial Master File (TMF); periodically review or QC the TMF to ensure overall inspection readiness, completeness and adherence to agreed-upon structure
  • Participate in the planning and execution of study specific investigator meetings and team trainings
  • Complete assigned responsibilities according to project timelines, corporate goals and study team milestones
  • May manage 1-2 direct reports in Clinical Site Operations (e.g. Associate Manager or Specialist)
  • Participate in departmental initiatives

 

Qualifications and Preferred Skills

  • Bachelor’s degree required
  • Approximately 8+ years of experience in Clinical Operations specifically in the field of managing and/or monitoring clinical trials
  • Has skills and expertise in oversight, mentoring and coaching of CRAs
  •  Independent professional who proactively communicates frequently and effectively.
  • Detail oriented, organized and committed to quality and consistency
  • Excellent team-interaction skills and ability to work successfully in cross-functional teams
  • Ability to work in a dynamic environment with a high degree of flexibility
  • Willingness to travel; approximately 30%

Exact Compensation may vary based on skills, experience and location.

Pay range

$150,000 - $175,000 USD

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