Clinical Trial Manager

Pfizer Boulder , CO 80301

Posted 3 months ago

This position resides in our Boulder, CO or Morrisville, NC offices and will be responsible for leading the execution of oncology clinical studies to required quality standards, on schedule and on budget. This is an office-based position

ROLE RESPONSIBILITIES

  • Oversees the delivery of studies to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines

  • Provides Clinical Operations leadership to CROs, other vendors, CRA team, internal study team, and Project Coordinators

  • Develops timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines

  • Responsible for developing and implementing robust contingency and issue management plans to solve complex issues that impact study or program milestones

  • Manages staff and provides technical advice to team members

  • Disseminates clinical study communications to all functional groups and leads study and team meetings

  • Interacts with clinical research investigators and sites

  • Interacts with Senior Management to report on progress of milestones

  • Organizes, attends, presents and provides training at investigator meetings

  • Assists or leads development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)

  • Travel required: up to 20%

BASIC QUALIFICATIONS

BA/BS or higher degree

  • Recent oncology experience in the last 3-5 years required

  • 5+ years' experience in clinical study or program management, including study start-up, conduct, and close-out of trials (level determined by experience)

  • Solid technical knowledge of oncology therapeutic area required

  • Experience in oversight and management of Clinical Research Organizations (CROs), central laboratories, and other vendors required

  • International trial management experience desired

  • Phase I study management experience desired

  • Demonstrated ability to develop operational strategy for clinical studies, including development of timelines, communication plans, risk management/contingency plans and budgets

  • Line and matrix management experience preferred

  • Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations

  • A strong communicator with excellent verbal and written communication skills

  • A highly collaborative person who is able to respond to constantly changing circumstances and needs

  • Strong leadership skills, with demonstrated project or program management

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

#LI-PFP

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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Clinical Trial Manager

Pfizer