Puma Biotechnology, Inc. · 13 hours ago
Senior Clinical Trial Manager - Remote Position
United States
Full-time
Remote
Senior Level
$140K/yr - $170K/yr
6+ years expPuma Biotechnology Inc. is a company focused on innovative cancer therapies, and they are seeking a Senior Clinical Trial Manager to oversee the execution of clinical trials. The role involves managing all clinical aspects of studies, ensuring compliance with regulations, and leading cross-functional teams to achieve study deliverables.
BiotechnologyMedicalTherapeutics
Responsibilities
Manages all clinical aspects of a study, including but not limited to the following:
Assesses operational feasibility and is instrumental in start-up execution
Manages comprehensive study timelines and metrics, and oversees adherence to them
Participates in management/oversight of vendors; reviews vendor reports, budgets, and metrics; reviews and approves clinical vendor invoices against the approved budget
Provides input and/or reviews study-related clinical plans and documents (eg, Clinical Project Plan, Clinical Monitoring Plan, Patient Diary, CRF Completion Guidelines)
Prepares/reviews site-related documents (eg, 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 (eg, study team meetings, investigator meetings)
Maintains study trackers (eg, 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, as appropriate; participates in site monitoring visits, as appropriate
Interacts with the study Medical Director and members of the cross-functional study team, as needed; interacts frequently with cross-functional internal and external personnel (eg, 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 the efficient management/oversight of the clinical trial
Qualification
Required
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 required, with a minimum of 3 years of trial management experience
Strong understanding of GCP, ICH and knowledge of regulatory requirements
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 (eg, 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
Preferred
Oncology experience
Global trial experience
Benefits
An annual bonus target
A robust benefits package
Company
Puma Biotechnology, Inc.
At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$809.3MKey Investors
Athyrium Capital Management LPAdage Capital Management
2022-03-10Post Ipo Equity· $10M
2021-07-26Post Ipo Debt· $125M
2017-11-02Post Ipo Equity· $100M
Leadership Team
Maximo Nougues
Chief Financial Officer
Gordon Esplin
Chief Accounting Officer
Recent News
2025-12-24
2025-11-08
Company data provided by crunchbase