Pfizer Site Relationship Partner I in Remote, Maryland
The Site Relationship Partner is the main Pfizer point of contact for investigative sites; accountable for site start-up activities through site activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies. The Site Relationship 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 Partner proactively collaborates with key stakeholders and provides local intelligence to country outreach surveys, investigator strategies, and Pfizer pipeline opportunities. Additionally, the Site Relationship Partner will help coordinate with other roles and functions that will interface with study sites, thereby, simplifying communications and enhancing overall visibility into and confidence of quality of site-level activities.
Accountable for site start-up and activation • Deploy GSSO site strategy (e.g., insourced/targeted) by qualifying and activating assigned sites, while coordinating Pfizer functions to standardized processes and deliver site activation. • Conduct study start up activities at the site level including but not limited to PTA, SIV (as applicable), including management of issues that may compromise time to site activation and/or initiation. • Partners with pCRO/monitor to ensure site activation and support site monitoring readiness in anticipation of first subject first visit. Responsible for relationship building and operational management • Support assigned investigator sites through site close out. • Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts by colleagues. • Lead effective site recruitment planning, consistent with global and/or country plan and local targets; Provide enrollment support and ensure progress by responding to recruitment issues from investigators. • Maintain regular communications with investigator sites to rev. 03/01/2019 gather status updates. • Act as operational point of contact for all site level questions, liaising with and escalating to appropriate teams to respond and resolve questions. • Maintain system management (e.g., Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms. • Review and manage site practices that differ from Pfizer practices and liaise with study teams and study management. • Inform and educate investigator sites of Pfizer pipeline opportunities that may be a good fit. • Support development and delivery of decentralized capabilities at investigator sites • May act as a Subject Matter Expert on Pfizer systems and processes Responsible for proactively providing local intelligence • Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable). • Provide input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes, practices, and associated site performance metrics. • Provide regional exploration/territory development growing adjacent opportunities where possible. • Provide support to the Country Trials Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies (as applicable). 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 Activation Partner, Site Excellence Partner, Country Trials Managers and Study Management. The Site Relationship Partner may be required to support some or all of the primary responsibilities of the Site Excellence Partner, as described in the Site Excellence Partner Job Description. Including but not limited to: safeguarding quality and patient safety at the investigator site, site and monitoring oversight, and 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.
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.
Experience with study start-up activities through site initiation and activation.
Experience with drug development and monitoring.
Experience implementing centrally designed and developed initiatives on a local basis 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 Behavioral Competencies.
Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development.
Proactively manages change by identifying opportunities and coaching self and others through the change.
Demonstrated ability to introduce new ideas and implement them.
Effectively overcoming barriers encountered during the implementation of new processes and systems.
Identifies and builds effective relationships with customers and other stakeholders.
Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships rev. 03/01/2019.
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Travel regularly within country and region is required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel regularly within country and region is required.
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.
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.