Clinical Trial Manager

Company Overview:

Vivace Therapeutics is an oncology-focused small molecule drug discovery and development company adopting a capital-efficient approach to bring novel therapies to patients in need. Our experienced management team and world-class scientists work to advance promising drugs and therapeutic technologies that we believe can help conquer cancer.

Position Summary:

Reporting to the Director of Clinical Operations, this manager's role is responsible for hands-on oversight of the day-to-day operations of complex Phase I-III clinical oncology trials. Including CRO and vendor management (trial management, central lab, supply chain/depot), data review and management, and sponsor trial oversight activities (monitoring report review, protocol deviation review, routine TMF monitoring, and sponsor quality site visits).

Primary Responsibilities

• Ensure clinical trial compliance with protocol, FDA, EMA, ICH-GCP, and other relevant regulatory guidelines
• Management of day-to-day CRO activities, including oversight of patient and site management, site monitoring, clinical Trial Master File (TMF) maintenance, and adherence to CRO plans, SOPs and trial manuals (lab and pharmacy)
• Work closely with CRO data and site management to ensure accurate and timely data collection, source data verification, query resolution and data review; including oversight of clean patient tracker
• Support Vivace clinical scientist to review case report forms, evaluate clinical data, and ensure its integrity and accuracy
• Oversight of CRO and vendor budgets to ensure work is completed within the scope of the approved work order and invoices are accurate
• Ensure that all adverse events are reported promptly and accurately to the relevant authorities
• Identify and mitigate potential risks that could impact trial participate safety, trial timelines, data quality, or compliance, and escalate as appropriate
• Support cross-functional teams by organizing meetings, preparing agendas, and documenting action items and decisions made

Position Qualifications and Experience

• Bachelors in life sciences preferred
• Oncology experience preferred
• Experience in managing Phase I-III clinical trials preferred
• Minimum of 5+ years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industries. May consider Associate Clinical Trial Manager with fewer than 5 years' experience.
• Knowledge of ICH-GCP, FDA, and EMA regulatory requirements
• Experience working with and navigating electronic data capture (EDC) systems
• Strong communication and organizational skills
• Experience in site monitoring is a plus

• Ability to work in a small remote team-oriented environment

This job description is intended to outline the primary duties, qualifications, and responsibilities of this role and may be amended from time to time.

The Company maintains highly competitive, performance-based compensation programs. Individual compensation will be decided based on demonstrated experience and will include base salary plus annual performance bonus and equity opportunities.

Location/Travel:

This position can be remote with ability to travel to company headquarters in San Francisco Bay Area as needed.