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Study Start Up Project Manager (FSP)

Job ID 68305BR Spain - Any Region - Home Based
The Start Up Project Manager (SSU PM) 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, Clinical Research Organization (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 (CTA) 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 Start Up Subteam and a core member of the Study Management Operations Sub team.
  • Ad-hoc member of the Core Team Meeting throughout study start up.
  • Accountable for startup of sites to be Ready to Enroll.
  • Organizational Relationships:
  • Reports to the ExecuPharm (EP) assigned Line Management with day-to-day direction from Client.
  • Refer to Organizational Chart for details regarding assigned role and associated reporting structure
Primary Duties:
  • 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 Relationship Partners and Site Activation Partners.
  • 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 Decision View Study Optimizer (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 identification, up to and including, site Ready to Enroll, incorporating input from Director of Clinical Site Management (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 Targeted sites, drive the Site Relationship Partner 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 Investigator Initiation Package (IIP) documentation including site contracts and budgets and Informed Consent Document (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

Qualifications

  • Must have a BS/Nurse with 5 years relevant experience or MS/PhD with 3 years relevant experience
  • Extensive global clinical trial/study management experience
  • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
  • Prior 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. Project Management tools, Gantt charts spreadsheets, metrics & data flow management).

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