Job Description

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.

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 (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

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 required, 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

Other Duties

Please note this is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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, depending on the schedule for the day. This position occasionally requires working outside of these hours, and may extend to evenings and weekends as business needs require.

Work Environment

This position operates in a professional, virtual environment, working from a remote location, usually the employee's home.

Travel

Travel (including air) may be required up to 25%. This may include carrying a laptop, lifting luggage and possibly long flight times.

Physical Demands

This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, 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 someone with advanced skills and/or experience.

At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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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.

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