Pfizer  GSSO in Remote,
The Study Start Up Project Manager is responsible for defining, developing and delivery of the Global Study Start Up Project Plan by partnering with Study Manager, Clinical Trial Application Group, Clinical Research Site Assistants, CRO Study Start Up and Site Operations Relationship Lead and others as required for Phase 3 and other supported studies.
Partner with Study Optimization to leverage site intelligence to inform the Start Up Project Plan.
Partner with the Targeted Site Investigator Network Strategy Implementation Lead to ensure accelerated start up strategies are leveraged at Targeted sites.
Partner with Clinical Trial Application and CRO Start Up functions to align all country and site activities to Start Up Project Plan
Identify risks to site activation and develop mitigation plans. This role is also accountable for resolution of Site Activation escalations for Study Teams including offering options for mitigation (both at the study and site level).
Leader of the Study Start Up Subteam and a core member of the Study Management Operations Subteam.
Ad-hoc member of the Core Team Meeting throughout study start up.
Accountable for start up of sites to be Ready to Enroll.
Leader of the Site Activation Subteam and a core member of the Study Management Operations Subteam
Lead the cross functional site activation team - internal plus CRO, utilizing the appropriate team members to support implementation of the Start Up Project plan.
Ensure accelerated start-up for Targeted Sites leveraging the Site Operations Relationship Lead and Clinical Research Site Assistant.
Drive delivery of all Targeted and CRO supported sites that are "Ready to Enroll" to the Start Up Project plan.
Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager through the Study Management Operations Subteam with the CRO.
Oversee and drive execution of study start-up activity at CRO.
Ensure alignment to the DVSO scenario planning.
Accountable for defining, developing and delivery of the Global Study Start Up Project Plan, including:
Track and communicate with Study Management Operations Subteam & Core Team.
Drive alignment of CRO study start up plan to country and site level.
Agree to deliverables on a site-level basis with the CRO and monitor adherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.
Use site activation reporting tool following site ID, up to and including, site Ready to Enroll, incorporating input from DCSM regulatory submission/approval timelines in order to achieve agreed upon milestones in DVSO.
Implement strategies within Study Start Up Subteam on assigned study to ensure consistent and efficient communications internally and with the CRO.
For PFE Targeted sites, drive the Site Operations Relationship Lead to manage site activation timelines across targeted sites to the level of the individual site:
Understanding critical path activities at the site level
Ensure planning for individual components of IIP documentation (including site contracts and budgets and ICD) in partnership with CRO Start Up and/or Clinical Research Site Assistants.
Ensure site readiness activities are considered in the overall timelines for each site to ensure ready to enroll
Supplies on site (IP and non clinical supplies)
Training (break blind, systems training, etc.)
Leverage all available intelligence to inform the Study Start Up Strategy
Partner with Site Intelligence to ensure clear communication of data.
Obtain CRO, CTA, Country and Targeted Site level input to plans.
Identify risks to site activation and develop mitigation plans, including providing input to OpCo materials
Identify and capture key risks to site activation for inclusion in OpCo presentations.
Develop site activation mitigation plans and monitor effectiveness through Study Start Up Subteam.
Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders
Extensive global clinical trial/study management experience
Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
Must have a BS/Nurse - 5 years relevant experience or MS/PhD - 3 years relevant experiencePrior Experience Preferred:
Demonstrated knowledge of site selection, site activation, site readiness interdependencies
Demonstrated experience leading cross functional teams
Demonstrated experience in Project Management activities and responsibilities
Previous CRO oversight experience
Technical expertise in the use of Site Activation tools
Ability to manage complex processes
Ability to manage in a matrix environment
Risk Identification & Mitigation
Strategic Planning, Analytical and Problem Solving Skills
Critical Path Analysis
Country level awareness and strong interpersonal skills
Excellent communication skills, both written and verbal. Must be fluent in English.
Detail oriented & possesses technical expertise (e.g.,PM tools, Gantt charts spreadsheets, metrics & data flow management)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Remote (home) based position
Limited international travel required (2-3 times/year)
Application Deadline: December 5 (Thurs), 2019 6:00pm
Please apply via Pfizer Career Website Only.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.