Site Excellence Partner II
The Site Excellence Partners are accountable for safeguarding the quality and patient safety at the investigator site and are responsible for site and monitoring oversight. The Site Excellence Partner is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. The Site Excellence Partners are accountable for identifying CRA performance issues and are responsible for ensuring appropriate corrective and preventative actions are put in place.
Responsible for process, standards, and oversight:
- Responsible for site and monitoring quality, regulatory and GCP compliance.
- Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.
- Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
- Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation
- Leads in conjunction with local country intelligence to to proactively identify risks.
- Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
- Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.). Demonstrate use of data to enhance quality and accelerate study delivery.
- Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control.
- Conduct and report oversight activities, both remote and onsite visits, according to Pfizer requirements and standards.
- Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
- Work with CRO CRAs, and other CRO colleagues as appropriate, to drive resolution of oversight issues.
- Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.
- Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery.
- Identify potential improvements for Pfizer processes.
- Review of monitoring visit reports.
- Serve as key contributor to process improvement initiatives and may lead local area initiatives.
- Support in external environment shaping activities for a country.
- Act as a Subject Matter Expert for a category or global processes within the GSSO organization.
- Support onboarding of new colleagues in country.
Protocol Site Oversight
- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
- Seek assignment to complex protocols driven by demonstrated capability in role.
Site and Study Management Interface
- Support local Investigator relationship management with the Site Relationship Partner.
- Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.
- Support the resolution of operational obstacles at the site / country level in order to advance the site and study deliverables.
- Support vendor relationship management at country-level.
- The Site Excellence Partner may be required to support some or all of the primary responsibilities of the Site Relationship Partner, as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and Pfizer pipeline opportunities. The Site Excellence Partner may be required to support additional primary responsibilities of the Site Relationship Partner in study start up, activation, and execution to the plan for targeted sites, helping coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Pfizer communications and enhancing overall visibility into and confidence of quality of site level activities.
QUALIFICATIONS / SKILS
Training and Education
- A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience:
- BS/BSc/MS/MSc or equivalent + 7 years of clinical research experience and/or quality management experience
- Skills in more than one language are an advantage in this role. English is essential
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
- Site Management/Monitoring (CRA) experience (preferred)
- Project management experience preferred in the clinical development area
- Ability to lead, troubleshoot and influence for delivery
- Independent approach
- Demonstrated knowledge of clinical research processes and global and local regulatory requirements; ability to gain command of process details • Demonstrated ability to work in cross-functional matrix environment Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions
- Challenges people to surpass themselves in reaching their objectives using innovative solutions
- Utilizes and encourages innovative approaches to build and maintain a competitive advantage
- Acts as a champion of change across the area/region/countries; uses facts, logic and personal credibility to influence the successful implementation of process improvements
- Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration
- Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
- Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures
- Motivates through example, commitment, loyalty and enthusiasm
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Availability to travel regularly within country and region is required.
Other Job Details:
Last Date to Apply for Job: October 18th, 2021
Eligible for Employee Referral Bonus: YES
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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.Medical#LI-Remote #LI-PFE