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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Study Start Up Project Manager (FSP) France, Spain or Netherlands

Job ID 61973BR France - Any Region - Home Based
Your time here

ExecuPharm (a Parexel Company)-acting as an FSP (Functional Service Provider) is offering a full-time permanent role, competitive annual salary combined with an excellent benefits package. For the ambitious and dedicated Individuals, we are offering a career progression path within the Organisation.

Our client-one of the most prestigious Pharmaceutical Companies in the world-we are currently looking for a Start-up Clinical Project Manager to be fully home-based.

Position Purpose:
  • 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.

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.
  • 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.
  • 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 Supplies on site (Investigational Product (IP) and non-clinical supplies)
  • Identify and capture key risks to site activation for inclusion in SciOps presentations.
  • Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training
  • Adheres to EP and Client SOPs and processes

Qualifications

More about you

Essential Skills and Education:
  • 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

Preferred Experience:
  • 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
A little about us

For over 30 years, we at Execupharm have been an industry leader in providing innovative, flexible and customized outsourcing solutions. Our Functional Service Provider (FSP) team was established to help clients accelerate pipeline development.

With over 5,000 Global FSP resources, with an additional 25,000+ pre-screened potential candidates in our system, we are available to partner with you to provide tailored solutions that address your unique needs.

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