(Clinical Trials) Quality Appraiser (Manager) - Clinical Research Unit (PCRU)
Location:
Posted:
September 02, 2016
Reference:
1037998


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The PCRU Quality Appraiser will perform clinical monitoring activities in accordance with prevailing laws, GCP/ICH Guidelines, the company standards and PCRU SOPs. This position is responsible for ensuring patient safety and quality study execution as well as the overall integrity of assigned studies through the use of independent judgement to assess adherence to study protocol and regulations.

Responsible for monitoring quality of study execution for PCRU studies:
• Ensure overall quality and regulatory and GCP compliance
• Conduct and report monitoring activities
• Proactively identify, manage and escalate site issues
• Ensure resolution of site issues in order to maintain sound investigator relations
• Maintain a thorough knowledge of protocol

Responsibilities
• Perform on-site monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements and complete appropriate documentation as required
• Attend protocol training to ensure clear understanding of the protocol requirements
• Assess and ensure overall integrity of study and adherence to protocols, guidelines, regulations and training requirements
• Evaluate overall performance of site and site staff
• Ensure compliance and understanding of study requirements by site staff
• Apply judgement and knowledge to independently resolve site issues
• Interpret data to identify protocol deviations or major risks to data integrity
• Provide recommendations regarding site specific actions and use judgement and experience to assess ability of site staff
• Understand project scope and timelines and be able to provide input and manage project objectives to meet timelines
• Review and verify case report forms and other clinical data for completeness and accuracy
• Monitor patient safety, identify and address any protocol deviations/violations in a timely manner
• Generate queries and manage resolutions with site personnel
• Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations

Qualifications
• Experience: In general candidates for this job should have the following levels of education and relevant experience:

• A scientific or technical degree is preferred (MS or BS with 3-5 years experience)
• Experience with clinical site monitoring (2 years desired)
• Knowledge of GCP/ICH Guidelines and other applicable regulatory requirements
• Strong organizational and influencing skills
• Excellent communication, presentation, interpersonal skills, both written and verbal

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
A little about us:
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