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Site Relationship & Excellence Partner II

Pfizer
Los Angeles, CA 90012
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**JOB SUMMARY**



The Site Relationship & Excellence Partner 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 Relationship & Excellence Partner 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 Relationship & Excellence Partner 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.



**JOB RESPONSIBILITIES**



**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.



Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership.



**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, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required. Apply clinical development strategy in the assessment of country and site selection at the asset level.



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.



Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy.



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.



Develop a solid understanding of targeted site-specific/institution-specific requirements to apply this knowledge to future site activities or the development of new targeted site relationships.



**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 regulatoryand/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.



Actively pursue possible efficiencies and develop best practices in the delivery activities for site start up and performance at the targeted site level to increase investigator/site satisfaction and strengthen targeted site relationships with Pfizer. Seek assignment to complex protocols due to demonstrated capability in responsibilities.



**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 Excellence Partner 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.



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.



**QUALIFICATIONS/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 + 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 required.



**Prior Experience**



Experience implementing centrally designed and developed initiatives on a local basis



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



**Technical Competencies**



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



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Availability to travel regularly within country and region is required



Eligible for Employee Referral Bonus: YES



\#LI-PFE



\#LI-Remote



**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.



Medical



\#LI-Remote #LI-PFE
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Site Relationship & Excellence Partner II

Pfizer
Los Angeles, CA 90012

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