Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing ... Ensures all clinical trials are executed in compliance with international GCP guidelines ...
Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing ... Ensures all clinical trials are executed in compliance with international GCP guidelines ...
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Remote International Biotech information
What are the key skills and qualifications needed to thrive as a Remote International Biotech professional, and why are they important?
How does working remotely in an international biotech role impact team collaboration and communication?
What is a Remote International Biotech job?
What is the difference between Remote International Biotech vs Remote International Biotech Research Associate?
| Aspect | Remote International Biotech | Remote International Biotech Research Associate |
|---|---|---|
| Credentials | Bachelor's or higher in biotech, life sciences, or related fields | Bachelor's or higher in biotech, life sciences, or related fields; some roles prefer or require additional certifications |
| Work Environment | Primarily remote, collaborating with international teams | Primarily remote, focused on supporting research projects and data analysis |
| Employer & Industry Usage | Biotech companies, research institutions, pharma firms | Biotech companies, research labs, pharmaceutical firms |
Remote International Biotech is a broad role involving various biotech functions remotely, while a Remote International Biotech Research Associate specifically focuses on supporting research activities and data analysis. Both roles require similar educational backgrounds and operate mainly in remote settings within the biotech industry, but the Research Associate role is more specialized in research support tasks.

Senior Clinical Trial Manager - Remote Position
Puma Biotechnology, Inc.Los Angeles, CA โข On-site, Remote
Full-time
Posted 27 days ago
Job description
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 job description 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.
#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.
About Puma Biotechnology
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
201 - 500 Employees
Headquarters location
Los Angeles, CA, US
Year founded
2010