Senior Clinical Trial Manager - Remote Position

Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.

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, ensures completion of study deliverables, typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.), proactively identifies and resolves clinical project issues, and participates in process improvement initiatives as required.

Major Duties/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.

• 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

• Bachelor’s degree or equivalent combination of education/experience, preferably in science or a…