Site Relationship & Excellence Partner
Oportunity in leading research-based biopharmaceutical company
Active role investigating COVID-19
Sobre nuestro cliente
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world's best-known consumer healthcare brands. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life-threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.
Descripción de la oferta
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.
* Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
* 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.
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.
* 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.
* 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.
* 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.
* 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
* 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.
Site and Study Management Interface
* 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.
Page Group Argentina is acting as an Employment Agency in relation to this vacancy.
Perfil buscado (Hombre / Mujer)
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 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
* Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development
* Demonstrated ability to introduce new ideas and implement them
* Effectively overcoming barriers encountered during the implementation of new processes and systems
* Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships