Clinical Trial Manager, Immunology

This is a fully remote position, open to applicants in Florida.

📋 Description

• Collaborates closely with various internal teams, vendors, and clinical sites.

• Ensures that clinical trials are executed promptly and adhere to SOPs, ICH/GCP standards.

• Takes charge of leading and managing the execution of intricate drug/device combination immuno-oncology clinical trials from initiation to closeout.

• Acts as the primary liaison for clinical site personnel regarding trial activities and progress.

• Engages in the development of protocols, CRFs, and strategic plans.

• Compiles metrics and updates for management review.

• Prepares and delivers both written and verbal status reports on clinical trials.

• Proactively identifies potential study challenges and risks, proposing and implementing effective solutions.

• Participates in and facilitates the selection process for CROs/vendors for outsourced activities.

• Manages interactions with CROs, ensuring sponsor oversight of operational activities.

• Prepares, reviews, and approves study-related documentation.

• Develops and maintains the Project Team List for assigned clinical trials.

• Oversees clinical monitoring activities to ensure compliance with Good Clinical Practice (GCP).

• Contributes to the development, review, and implementation of departmental SOPs and processes.

• Organizes and manages internal team meetings, investigator meetings, and other trial-specific gatherings.

⛳️ Requirements

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

• Additional clinical trial certifications (e.g., ACRP, SOCRA) are advantageous.

• A minimum of 5 years of experience in clinical research and clinical operations.

• Knowledge of clinical trial processes, Good Clinical Practice (GCP), and ICH guidelines.

• Extensive experience in oncology clinical trials.

• Experience with phase I-II oncology studies from study initiation to data lock.

• Strong understanding of GCP, ICH guidelines, and regulatory requirements.

• Excellent scientific acumen and the ability to comprehend complex scientific and technical concepts.

• Familiarity with 21CFR, ISO, ICH, GCP, and pertinent regulations, standards, directives, and guidelines is crucial.

• Outstanding analytical and research skills, with a meticulous attention to detail.

• Exceptional communication, organizational, and problem-solving abilities.

• Capability to work independently and collaboratively in a fast-paced, deadline-driven matrix environment.

• Ability to prioritize tasks and complete assigned work within deadlines.

🏝️ Benefits

• This position typically qualifies for cash incentive compensation.

• Equity incentive compensation is also offered.

• Employee benefits are provided under the Company’s benefit plans.