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Reference #: 1002446155-philadelphiaJob Overview:Start Up Associate Project Manager - RegulatoryHomebased in the USWhy settle for one thing when you can have everything?Covance gives you the best two-for-one opportunity for career growthand.nbsp; Who doesn.and.#39;t want twice the perks? Working at Covance-one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!As a Covance employee dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, Covance has an FSP opportunity to match your area of expertise.You will enjoy the best of both worlds-all the benefits that come along with Covance.and.#39;s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.Covance.and.#39;s FSP model is flexible and scalable. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.Covance.and.#39;s reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.We are seeking a Start Up Associate Project Manager to Lead start-up team during study start-up phase liaising directly with Lead Start Up Project Manager or Project Lead, core team members and the client, as applicable. This position specializes in ICF creation, language, and negotiation.In this role, the selected candidate will serve as client.and.#39;s contact for start-up and maintenance processes and oversight; be responsible for establishing a strong working relationship with client.and.#39;s project teams; monitor and control start up project schedule and scope; proactively engage in.and.nbsp; both quality assurance and risk management activities to ensure project deliverables are met; and initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projectsand.nbsp;Additional responsibilities include:Creating ICFs including language and negotiationDeveloping a site activation and maintenance strategy in conjunction with the Project Lead, other functional groups and the client to ensure start-up and maintenance deliverables are completed within agreed project timelines and in accordance with client.and.#39;s expectationsCreating/reviewing required project start-up plans; distributing, implementing and monitoring compliance to project plans and revise as necessary; and reviewing Client vs CRO responsibilities as related to start-upUnderstanding client expectations for deliverables/milestones, and liaising with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the projectReviewing and providing input to core study documents, as applicableProactively managing site activation and maintenance progress, expectations and deliverables to a Lead Start Up Project Manager or the Project Lead/client, as applicablePresenting at external and internal meetings including, but not limited to: project core team and client meetings, Chapter Meetings, Kick Off MeetingsDistributing start-up and maintenance related documents to local start-up staff and oversee the customization to local requirementsOverseeing ethics/regulatory bodies submission, approval status and coordinating addressing queries ensuring required timelines are metEnsuring preparation and distribution of core and country specific contract and budget templates to applicable project team membersOverseeing Investigator Package compilation and green light approval regionally and/or globally
