Senior Manager Site Care Partner
hace 4 semanas
The Site Care Partner Senior Manager is responsible for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies. This role acts as a 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.
Key Responsibilities
Deploy GSSO site strategies by qualifying and activating assigned sites
Support processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection
Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable)
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
Maintain a thorough knowledge of assigned protocols
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.)
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 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
Excellent 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
Behavioral Competencies
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
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