Site Care Partner II

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. The Site Care Partner is a key Pfizer point of contact for investigative sites throughout a study life cycle. Accountabilities include: Building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies Site-level recruitment and accountable for safeguarding the quality and patient safety at the investigator site. Subject Matter Expert aimed to optimize country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Pfizer pipeline opportunities. Ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is upheld throughout study lifecycle. Coordination with other roles and functions that will interface with study sites (e.g. CRA/Site Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. Site quality by utilizing and interpreting data from analytic tools, in conjunction with country intelligence and IRMS to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. Conducting study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV, including management of issues that may compromise time to site activation. Ensuring all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. Supporting country specific ICD review and deployment when applicable. Ensuring follow up activities ’completion post PTA and SIV to ensure site readiness for FSFV. Partnering with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visit. Relationship building and operational quality of the site Providing study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. Ensuring the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study Effective site recruitment planning and delivery, consistent with global and/or country plan and local targets. Establishing and maintaining relationships with Site Organizations and Strategic Partners Accountable for study conduct and close-out. Reviewing Site Reports and related issues. Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership. Act as a Subject Matter Expert on Pfizer systems and processes. Requirements: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years’ experience). Proficiency in local language preferred. English is required. Demonstrated experience in site management with prior experience as a CRA/Site monitor. Demonstrated experience in start up activities through to site activation. Demonstrated experience in conduct and close out activities. Demonstrated knowledge of quality and regulatory requirements in the United States. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Must demonstrate good computer skills and be able to embrace new technologies. Excellent communication, presentation and interpersonal skills. Ability to manage required travel (in the United States). Demonstrated networking and relationship building skills. Demonstrated ability to manage cross functional relationships. Ability to communicate effectively and appropriately with internal & external stakeholders. Ability to adapt to changing technologies and processes The Site Care Partner is a key Pfizer point of contact for investigative sites throughout a study life cycle. Accountabilities include: Building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies Site-level recruitment and accountable for safeguarding the quality and patient safety at the investigator site. Subject Matter Expert aimed to optimize country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Pfizer pipeline opportunities. Ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is upheld throughout study lifecycle. Coordination with other roles and functions that will interface with study sites (e.g. CRA/Site Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. Site quality by utilizing and interpreting data from analytic tools, in conjunction with country intelligence and IRMS to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. Conducting study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV, including management of issues that may compromise time to site activation. Ensuring all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. Supporting country specific ICD review and deployment when applicable. Ensuring follow up activities ’completion post PTA and SIV to ensure site readiness for FSFV. Partnering with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visit. Relationship building and operational quality of the site Providing study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. Ensuring the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study Effective site recruitment planning and delivery, consistent with global and/or country plan and local targets. Establishing and maintaining relationships with Site Organizations and Strategic Partners Accountable for study conduct and close-out. Reviewing Site Reports and related issues. Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership. Act as a Subject Matter Expert on Pfizer systems and processes. Requirements: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years’ experience). Proficiency in local language preferred. English is required. Demonstrated experience in site management with prior experience as a CRA/Site monitor. Demonstrated experience in start up activities through to site activation. Demonstrated experience in conduct and close out activities. Demonstrated knowledge of quality and regulatory requirements in the United States. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Must demonstrate good computer skills and be able to embrace new technologies. Excellent communication, presentation and interpersonal skills. Ability to manage required travel (in the United States). Demonstrated networking and relationship building skills. Demonstrated ability to manage cross functional relationships. Ability to communicate effectively and appropriately with internal & external stakeholders. Ability to adapt to changing technologies and processes Work Location Assignment:Remote The annual base salary for this position ranges from $116,000.00 to $193,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. 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