ROLE SUMMARY
The Site Care Partner is the main Pfizer point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site.
The Site Care Partner contributes to 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 under supervision. The Site Care 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 upheld throughout study lifecycle.
Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study sites (eg. Study 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.
The Site Care Partner is responsible for site oversight utilizing and interpreting data from analytic tools, in conjunction with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
JOB RESPONSIBILITIES
Accountable for site start-up and activation
- Deploy GSSO site strategies by qualifying and activating assigned sites.
- Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.
- Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
- Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
- Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV.
- Partners with site monitor to ensure site monitoring readiness in anticipation of first subject first visit.
- Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable.
Accountable for study conduct and close-out
- Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
- Review Site Monitoring Reports.
- During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under DCSO/ Senior SCP supervision. In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current.
- Review and manage site practices that differ from Pfizer practices and liaise with study management and Business Process Owners as needed.
- Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures.
QUALIFICATIONS
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- 5+ years experience.
- Demonstrated experience in site management with prior experience as a 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 applicable countries.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Good communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
- 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.
- Knowledge of country requirements for GCP that may be different to those of Pfizer Procedures.
- Effectively overcoming barriers encountered during the implementation of new processes and systems.
- Identifies and builds effective relationships with investigator site staff and other stakeholders.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To apply please visit our website www.pfizercareers.com and search job Site Care Partner I id 4919384.
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