Clinical Study Manager

Galvanize Therapeutics 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.The CSM is responsible for coordinating and managing all aspects of a clinical study, managing timelines and study budgets. The CSM works closely with line management in each functional area within clinical affairs, to ensure timely startup, conduct, completion, analysis and reporting of clinical trials.Key RequirementsEducation and TrainingBachelor's degree or equivalent combination of education/experience in life sciences or related field Knowledge of oncology therapeutic area preferred Additional coursework in clinical trial planning and execution strongly desired. 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 Skills and ExperienceMinimum 5 years of experience in managing clinical trials in either sponsor or CRO strong track record of successful trial initiation and execution5 years of experience in medical device clinical researchExperience 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 environmentStrong work ethic and demonstrated ability to deliver assignments on timeProficient 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 skillsComplete projects with high quality and minimal guidanceAble to handle a moderate volume of highly complex tasks within a given timelineOther: Up to 50%; mainly domestic and some international.Key ResponsibilitiesManages US and international clinical studies Responsible for study team leadership, team meetings and facilitation of investigator meetings Serves as point of contact for study Principal Investigator(s) Establishment of detailed study timelines using tools such as MS Project, Excel and other project management tools Establishment of detailed study budgets, tracking spending vs. plan and re-forecasting as needed Ensures timely development of study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms Collaborates with line management on clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out Participates in identifying, selecting, and monitoring the performance of clinical sites May conduct routine monitoring visits or co-monitoring, start up and closeout visits, as required. Establishes and maintains strong relationships and communication with sites and site staff, as project manager Identify, conduct and document training sessions needed to ensure study-level compliance and understanding Ensures development of study-specific training tools and aids 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 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 to industry best practices and trends. Serves as liaison with R&D/operations on investigational product supply forecasting Developing appropriate early warning systems of potential obstacles to the successful completion of the study; analyzes information and develops innovative solutions to challenges Ensures studies are conducted according to standard operating procedures 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 skills, qualifications, experience, and location.Due to the nature of our business and the role, please note that Galvanize Therapeutics may require that you show current proof of vaccination against certain diseases including COVID-19.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.

Created: 2025-01-30