Senior Clinical Trial Manager

Senior Clinical Trial Manager - Remote Position Location: Los Angeles, CA. Department: Clinical Operations. The Senior Clinical Trial Manager (Senior CTM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables, typically working on studies with moderate to high complexity, proactively identifying and resolving clinical project issues, and participating in process improvement initiatives as required. Major Duties / Responsibilities Manages all clinical aspects of a study, including assessment of operational feasibility and start‑up execution. Manages comprehensive study timelines and metrics, overseeing adherence to them. Participates in management/oversight of vendors; reviews vendor reports, budgets, and metrics; and approves clinical vendor invoices against the approved budget. Provides input and reviews study‑related clinical plans and documents ("e.g., Clinical Project Plan, Clinical Monitoring Plan, Patient Diary, CRF Completion Guidelines"). Prepares/reviews site‑related documents ("e.g., site‑specific informed consent forms, study tools/worksheets, site contracts, site payments"). Assists in the selection of sites and countries; develops relationships with investigators and site staff. Oversees/provides study‑specific training and leadership to clinical research staff, including internal, contract, vendor, and site personnel. Plans, executes, and/or leads study‑specific meetings ("e.g., study team meetings, investigator meetings"). Maintains study trackers ("e.g., Study and Site Issue Log, Monitoring Visit Report Review Log, Protocol Deviation Log, CO Tracker for Shared Documents"). Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and applicable SOPs; participates in the planning of quality assurance activities and coordinates resolution of audit findings and CAPAs; ensures audit‑ready condition of clinical trial documentation including the TMF; reviews monitoring visit reports to ensure quality and resolution of site‑related issues; coordinates and assists in the planning of regulatory or ethics committee activities; and participates in site monitoring visits as appropriate. Interacts with the study Medical Director and members of the cross‑functional study team; interacts frequently with cross‑functional internal and external personnel ("e.g., Regulatory Affairs, investigators, vendors"). May be responsible for managing/mentoring less‑experienced Clinical Operations staff on the study team. Performs other tasks as assigned by the manager/designee to promote efficient management/oversight of the clinical trial. Skills and Abilities Excellent clear and timely communication, both written and verbal. Ability to handle a moderate to high volume of tasks within an established timeframe. Strong organizational and management skills and ability to prioritize. Effective problem solving, conflict resolution, leadership, and team‑building skills. Ability to build relationships within the team, across departments, and with external contacts ("e.g., vendors, site staff"). Proactively identify and resolve/escalate project‑related operational issues. Ability to work independently on routine assignments, or under supervision on new assignments. Familiarity with word processing, spreadsheet, and document management systems. Required Education and Professional Experience Bachelor’s degree or equivalent combination of education/experience, preferably in science or a health‑related field. Minimum of 6 years of clinical trial experience in pharmaceutical, biotech or CRO environments, with a minimum of 3 years of trial management experience. Strong understanding of GCP, ICH and knowledge of regulatory requirements. Preferred Education and Experience Oncology experience. Global trial experience. Position Type/Expected Hours of Work This is a full‑time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, with occasional work outside of these hours, including evenings and weekends as business needs require. Travel Travel (including air) may be required up to 25%, including carrying a laptop, lifting luggage, and possibly long flight times. Physical Demands The position is remote. Primary physical demands include extended periods of sitting and using office equipment (computer, keyboard, mouse), standing, walking, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds. Compensation Range The salary range for this role is $140,000 – $170,000 per year. Higher compensation may be available for individuals with advanced skills and/or experience. #LI-Remote Puma Biotechnology Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, status as a protected veteran, or any other characteristic protected by law. #J-18808-Ljbffr