Clinical Study Manager

About Galvanize Therapeutics

Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.

About The Role

The Clinical Study Manager is responsible for clinical operational planning, execution, and oversight of the conduct of clinical studies, managing timelines and study budgets, ensuring studies are performed in accordance with GCP, company SOPs, and other applicable rules and regulations. The Clinical Study Manager works closely with line management in each functional area within clinical affairs, to ensure timely startup, conduct, completion, analysis, and reporting of clinical trials.

Qualifications

Education and Training:

• Bachelor’s degree in life sciences or related field or equivalent combination of education/experience
• Minimum 5 years of experience in clinical trials in either sponsor or CRO with strong track record of successful trial initiation and execution
• Knowledge of oncology therapeutic area preferred
• Additional coursework in clinical trial planning and execution strongly desired
  
  

Skills And Experience

• Strong working knowledge of FDA regulations, ICH Guidelines, GCP, ISO 14155, and current industry practices related to the conduct of clinical trials
• Strong knowledge of US and international clinical regulations and guidelines
• Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.)
• Strong interpersonal communication (written and verbal), organizational and prioritization skills
• Able to work effectively under a fast-paced and changing environment
• Strong work ethic and demonstrated ability to deliver assignments on time
• Proficient in Microsoft Office products, including MS Project (or equivalent), with technical abilities to become proficient quickly with numerous other electronic systems (i.e. eTMF, EDC, and CTMS)
• Detailed oriented, with good organizational and time management skills
• Complete projects with high quality and minimal guidance
• Able to handle a moderate volume of highly complex tasks within a given timeline
  
  

Travel up to 50%; mainly domestic and some international

What You'll Do

• Manages US and international clinical studies. Manages clinical study planning and implementation from site selection, start-up, enrollment, maintenance, close-out, and monitoring the performance of clinical sites.
• Ensures timely development of study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, case report forms, training tools, and aids
• Ensures proper oversight of clinical site compliance with study protocols, SOPs, IRB(s), FDA regulations, and ICH/GCP guidelines
• Responsible for study team leadership, team meetings, and facilitation of investigator meetings
• Serves as point of contact for study Principal Investigator(s)
• Establishes and maintains strong relationships and communication with sites and site staff, as project manager
• Establishes detailed study timelines using tools such as MS Project, Excel and other project management tools
• Oversees all aspects of clinical study monitoring. May conduct routine monitoring visits or co-monitoring, start up and closeout visits, as required.
• Identifies, conducts, and documents training sessions needed to ensure study-level compliance and understanding
• Facilitates EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development, and other related activities
• Identifies any potential risks to the study timelines and/or conduct, proposes mitigations and implements mitigations with cross-functional team and management support; analyzes information and develops innovative solutions to challenges
• Contributes to the development of study site clinical trial agreement templates and budgets, tracks execution of agreements, rolling agreed-upon budget parameters into overall study budget, tracking spending vs. plan and re-forecasting as needed
• Works cross functionally with other departments such as Legal, Data Management, Finance and external vendors or contract research organizations (CRO), on all aspects of the clinical trial execution
• Develops and maintains relationships with and provides oversight for and assessment of external clinical trial vendors, CROs, core labs, etc. and keeps abreast of industry best practices and trends
• Serves as liaison with R&D/operations on investigational product supply forecasting
• Maintains and periodically evaluates clinical SOPs for compliance and continued process improvement
• Identifies processes that may need improvement and communicates this to line management
  
  

This role pays between $125,000 and $150,000 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.