- Accountable for site start-up and activation
· Deploy site strategy 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 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 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.
· Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership.
· May act as a Subject Matter Expert on Pfizer systems and processes
· Actively pursue possible efficiencies and develop best practices in the delivery activities for site start up and performance at the site level to increase investigator/site satisfaction and strengthen site relationships with Pfizer.
· Seek assignment to complex protocols due to demonstrated capability in responsibilities.
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 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.
- Provide input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.
- Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with the Country Trials Manager
- 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.
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 Manager 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.
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 + 7 years of clinical research experience and/or quality management experience; a nursing degree or associates degree in nursing may also be considered with extensive clinical
trial experience.
Experience
- Experience with study start-up activities through site initiation
- Experience with drug development and monitoring
- Experience implementing centrally designed and developed initiatives on a local basis
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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