The Senior Clinical Trial Manager (SCTM) 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 SCTM 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 10 years of experience in clinical research, clinical operations, or a related field including 5+ years working at a clinical research site (internships, research assistant roles, or prior experience in clinical trials is a plus).
  • Familiarity with clinical trial processes, Good Clinical Practice (GCP), and ICH guidelines.
  • Strong experience in phase I-II oncology studies including site management 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.
  • Bilingual in English/Spanish a plus.

Working Conditions:  Specify work environment:

  • The work environment shall be split between a virtual office environment and the Company headquarters in Fort Lauderdale, FL. Candidates should be located in Central or Eastern Time Zones.
  • Domestic and International travel up to 30%. Travel may increase based on study needs.
  • 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:  $150,000-$175,000

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.