The Clinical Trial Manager (CTM) works closely with various internal team members and vendors as well as clinical sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and company timelines. This position is responsible for leading and managing the conduct of complex drug/device combination immuno-oncology clinical trials from study start-up to closeout. The CTM shall serve as the primary contact for clinical site personnel for trial activities and progress, including responding to issues and recommending corrective actions.
Responsibilities:
• Participates in protocol, CRF and strategy development.
• Prepares metrics and updates for management, as assigned.
• Prepares and shares written and verbal reports on the status of clinical trials and significant issues impacting clinical trials.
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Participates in and facilitates CRO/vendor selection process for outsourced activities, as assigned.
• Manages CRO interactions, including sponsor oversight of operational functional activities.
• Prepares and/or reviews/approves study-related documents (Monitoring Plan, Communication Plan, Laboratory Manual, Procedures Manual, Pharmacy Manual, CRF Completion Guidelines, etc.).
• Develop and maintain the Project Team List for assigned clinical trials.
• Manages clinical monitoring activities ensuring compliance with Good Clinical Practice (GCP) and applicable regulations.
• Participates in the development, review, and implementation of departmental SOPs and processes.
• Recommends and implements innovative process ideas to impact clinical trials management.
• Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings.
• Serves as a liaison and resource for investigational sites of assigned studies.
• Reviews site study documents (informed consent template, study tools/worksheets, etc.).
• Participates in the training and evaluation of study personnel specific to assigned studies.
• Performs some or all the duties and responsibilities outlined for Senior Clinical Research Associate, as needed.
• Oversee and shepherd payments to sites through the payment approval process.
• All other duties as assigned.
Requirements:
• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field. Additional clinical trial certifications (e.g., ACRP, SOCRA) are a plus.
• At least 5 years of experience in clinical research, clinical operations, (recent experience as a CRA in oncology; academic site level experience in oncology as a study coordinator is preferred).
• Familiarity with clinical trial processes, Good Clinical Practice (GCP), and ICH guidelines.
• Strong experience in oncology clinical trials.
• Experience with phase I-II oncology studies from study start up through data lock.
• Solid understanding of GCP, ICH guidelines, and regulatory requirements.
• Strong scientific acumen and ability to grasp complex scientific and technical concepts.
• Familiarity with 21CFR, ISO, ICH, GCP, and relevant regulations, standards, directives, and guidance is essential.
• Excellent analytical and research skills, with a keen eye for detail.
• Exceptional communication, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced, deadline-driven matrix environment.
• Ability to set priorities and accomplish assigned work within deadlines.
Working Conditions:
• Specify work environment:
• The work environment shall be split between a virtual office environment and the Company headquarters in Fort Lauderdale, FL.
• Domestic and International travel up to 30%.
• Must have current passport or willingness to obtain immediately
• Must be able to successfully pass a background check, drug testing, and other applicable vendor credentialing requirements
• Ability to lift up to 35 pounds
• Regularly required to stand, sit, talk, hear, and use hands
• Prolonged periods of sitting and standing
Syncromune is an Equal Opportunity Employer.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range: $145,000-165,000
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.
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Remote
About the Company:
Syncromune, Inc.