Manager, Clinical Operations

The Manager of Clinical Operations is responsible for clinical operational planning and execution and oversees the conduct of clinical studies ensuring they are performed in accordance with GCP, company SOPs, and other applicable rules and regulations. The Manager will be responsible for the recruitment, hiring, training and development of assigned CRA operational staff.

Skills and Experience

• Bachelor’s degree or equivalent combination of education/experience in life sciences or related field
• Minimum 6 years’ clinical research experience in the medical device industry that includes relevant experience as a previous Clinical Study Manager, Clinical Program Manager, or Clinical Research Manager
• Strong working knowledge of FDA regulations, ICH Guidelines, GCP, ISO 14155, and current industry practices related to the conduct of clinical trials
• Strong interpersonal communication (written and verbal), organizational and prioritization skills.
• Able to work effectively under a fast-paced and changing environment
• Proficient in Microsoft Office products with technical abilities to become proficient quickly with numerous other electronic systems (i.e. eTMF, EDC and CTMS)
• Detail oriented, with good organizational and time management skills
• Complete projects with high quality and minimal guidance

Travel: Up to 25%; mainly domestic and some international.

Key Responsibilities

• Oversee clinical study planning and implementation from site selection through study closure
• Ensures proper oversight of clinical site compliance with Clinical Investigation Plans (CIP), SOPs, FDA regulations and ICH/GCP guidelines Provides oversight to assigned clinical affairs operational staff including training, coaching and performance management
• Plays a central role in identifying, selecting, initiating and monitoring the performance of clinical sites and studies across the portfolio
• Oversees the development of study-specific training tools and aids to ensure study-level compliance, the trending of metrics and CIP training
• Oversees all aspects of clinical study monitoring providing direction and accountability for the clinical operations team
• Ensures timely development of study related plans and documents which may include, but are not limited to CIPs, informed consent forms, recruitment plans, monitoring plans, and data management plans
• May organize committee(s) to review adverse events and protocol deviations
• Ensures adequate document collection and maintenance for audit-ready Trial Master Files
• May serve as the primary point of contact regarding operational questions and escalations
• Works with Sr. Management to communicate critical issues and drive to resolution
• Establishes and maintains strong relationships and communication with sites and site staff
• May represent Clinical Operations at internal and/or external audits
• May conduct routine monitoring visits or co-monitoring, start-up and closeout visits, as necessary
• Provide oversight for and assessment of external clinical trial vendors including CROs and core labs
• Develop and maintain relationships with external vendors, CROs, core lab, etc. and keep abreast of industry best practices and trends
• Develops and maintains relationships with cross-functional partners across the enterprise, participating in development activities as requested
• Periodically evaluates clinical SOPs for compliance and continued process improvement
• Identifies processes that may need improvement and communicates this to line management
• May develop and manage study-level budgets and operational costs

This role pays between $150,000 and $175,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.

Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.

Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.