Principal Clinical Data Manager - Remote Position

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

The Principal Clinical Data Manager is responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance.

Essential Functions

• Reviews listings to identify data discrepancies and tracks resolutions

• Works with Study team to design mock CRFs based on the protocol

• Leads database design, implementation and testing activities

• Supervises all data management deliverables and associated timelines with the CRO to ensure a quality database lock

• Coordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety and other departments, as needed, to resolve data issues

Competencies

• Excellent organizational skills and ability to prioritize tasks

• Must be able to work under tight timelines

• Possess excellent communication skills

• Anticipates change and reacts quickly and intelligently to accommodate business needs

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.

Supervisor Responsibilities

This position may manage employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.

Required Education & Experience

• Bachelor's Degree in a biological sciences or other medically related areas

• Minimum of 7 years of biometrics/data management or related experience in the biotechnology/pharmaceutical industry

• Familiarity with data management software (e.g. Medidata, Oracle Clinical)

• Working knowledge of coding dictionaries - MedDRA and WHODRUG

Preferred:

• Knowledge of Oncology clinical trials

• Nursing background

• Vendor management experience

• Familiarity with SAS

• Knowledge of Excel, Python, or R is helpful

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. This position regularly requires additional work hours and may require weekend work.

Work Environment

This job operates in a professional environment, while working remotely. This role routinely uses standard office equipment such as computers and telephones.

Physical Demands

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 work environment are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to handle or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Travel

Travel may be required (up to 5%).

Compensation Range

The salary range for this role is $165,000 - $205,000 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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