Clinical Trial Manager, Immunology

Syncromune•Fort Lauderdale, FL

1d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
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.
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

Nice To Haves

Additional clinical trial certifications (e.g., ACRP, SOCRA) are a plus.
academic site level experience in oncology as a study coordinator is preferred

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.