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The Site Oversight & Operations Relationship Lead is the main Pfizer point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret 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. This role is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. The Site Oversight & Operations Relationship Lead is the “face of Pfizer” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is that of “Partner of Choice.”
The Site Oversight & Operations Relationship Lead proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Pfizer pipeline opportunities. This role is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to being the main point of contact, the lead will help 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.
Indicate the primary responsibilities critical to the job.
Responsible for relationship building and management
- Usher investigator sites through site activation and study activities from study start up to close out.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
- Inform and educate investigator sites of Pfizer pipeline opportunities that may be a good fit.
- Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
Responsible for proactively providing local intelligence
- Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
- Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
- Review and manage site practices that differ from Pfizer practices and liaise with study teams and study management.
- Understand targeted site criteria as well as services delivered to target sites. Track that all such services are provided consistently and in a timely manner.
- Recommend potential targeted sites and conduct follow up with those sites as required.
Accountable for study start-up, activation, and execution to plan
For targeted sites
- Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating Pfizer functions to standardize processes and deliver activation in line with the targeted site strategy.
- Confirm (and educate where needed) that sites are familiar with Pfizer requirements for study start up and facilitate the availability of MSAs when feasible.
- Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
- Closely monitor and support study start up activities including review of key documents (e.g., local Informed Consent Document template), to address regulatory and/or ethics committee questions for targeted sites.
For all sites:
- Provide enrollment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level.
- Maintain a thorough knowledge of assigned protocols.
- Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by Pfizer colleagues.
- Support database release by facilitating query resolution, as needed.
Responsible for CRO and Study Management Interface
- Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Oversight Lead and Study Management.
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.
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.
Site and Study Management Interface
- Support local Investigator relationship management with the Site Operations Relationship Lead.
- Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Operations Relationship Lead and Study Team.
- Support the resolution of operational obstacles at the site / country level in order to advance the site and study deliverables.
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
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 + 5 years of clinical research experience and/or quality management experience.
- Skills in more than one language are an advantage in this role. English is required.
- 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
- Experience implementing centrally designed and developed initiatives on a local basis
- Demonstrated knowledge of quality and regulatory requirements for applicable countries
- Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation
- Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment
- Demonstrated success in prior scientific/technical/administrative roles
- Demonstrated experience in site activation
- Demonstrated networking and relationship building skills
- Demonstrated ability to manage projects and cross-functional processes
- Ability to communicate effectively and appropriately with internal & external stakeholders
- Ability to adapt to changing technologies and processes
- 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 i
Sobre la empresa
Pfizer, is an American multinational pharmaceutical corporation headquartered in New York City, New York, with its research headquarters in Groton, Connecticut. It is among the world's largest pharmaceutical companies by revenues.
Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, diabetology/endocrinology, and neurology. Pfizer's products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin for neuropathic pain/fibromyalgia); Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil, for erectile dysfunction); and Celebrex/Celebra (celecoxib), an anti-inflammatory drug.