Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs. 

POSITION SUMMARY: 

The Senior Clinical Trial Manager is accountable for the day-to-day operational management of at least one clinical trial in any Regulatory phase. Management includes trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and applicable regulatory requirements. Additionally, oversight includes management of Clinical Research Organization (CROs), support vendors, and internal staff.

This position reports to an Associate Director level or higher.  This position has the potential to be fully remote. Occasional travel will be required for in-person meetings. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Responsible for all facets of management of a clinical trial(s) including:
• Projection and management of study timelines
• Creation and management of clinical trial budgets
• Timely reporting of study performance metrics
• For outsourced studies, manages the CRO and support vendors
• Leads cross-functional study management teams (SMT); responsible for the timely setting of agendas, effective conduct of SMT meetings, and timely issuance of meeting minutes
• May lead sub-teams for a clinical trial or process
• Provides input on study-related meetings, including vendor selection, project kick-off, CRO project meetings, functional area-specific meetings, and Investigator meetings
• Manages the build of study systems (eg, EDC, IRT) and logistics (eg, lab kit and distribution) 
• Confirms proper training of internal and?CRO staff, and support vendors on the protocol and related processes 
• Ensures Site staff are trained on the study protocol, processes, and required systems, and that training documentation is collected and filed
• Reviews and approves study Plans
• Reviews and approves site monitoring visit reports in accordance with the applicable Plan; escalates risk findings accordingly? 
• Responsible for, or participates in data reconciliation, query resolution, and database freeze or lock
• Monitors CRO performance using standard Key Performance Indicators (KPI) to ensure compliance to Scope of Work 
• Responsible for financial tracking of all study costs, including CRO / vendor cost units, Investigator Grants, and invoices 
• Develops and tracks KPIs for site GCP/study compliance
• Ensures corrective action plans are created as required  
• Participates in selection of sites; may attend qualification, initiation, interim monitoring, and close-out site visits
• Provide input on Clinical Operations-specific SOPs, work instructions, process improvement, or Clinical projects
• Line management of Clinical Operations staff
• Occasional domestic US travel up to 25%, and internationally (on an “as needed basis”) in support of trial activities? 
• Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices 

• BS/BA degree in related discipline; or
• Certification in assigned area
• Minimum of seven (7) years of Clinical Operations experience, contingent on education/training
• Minimum four (4) years’ experience in study management is preferred, or equivalent experience gathered in a previous clinical trials management role
• Oncology experience is required
• Local to San Francisco/Bay Area preferred
• Experience as a Clinical Research Associate is preferred
• Line management experience is preferred
• Knowledgeable in CRF design, interactive response technology (IRT) systems, and clinical supply logistics
• Extensive clinical operations knowledge and cross-functional understanding of clinical trial methodology
• Exhibits ability to learn and apply foreign regulations to the clinical trial process
• Knowledgeable in Good Clinical Practice and ICH requirements
• Strong analytical, organizational, and communication skills
• Working knowledge of MS Office and MS Project
• Ability to work either independently or in a team environment

JOB COMPLEXITY:   

• Works on assigned problems of complex scope where analysis of situation or multiple factors is required
• Exercises judgment within defined procedures and practices to determine appropriate action
• Builds productive internal and external working relationships

The expected salary range for this position is $175,000 - $195,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. 

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen. 

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.