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  • ID
    #31002729
  • Salary
    TBD
  • Source
    Labcorp
  • Date
    2022-01-11
  • Deadline
    2022-03-12
 
Full-time

Vacancy expired!

Job Overview:Senior Study Manager - Oncology - RCCRemote in the USA or CanadaWhy settle for one thing when you can have everything?Labcorp Drug Development gives you the best two-for-one opportunity for career growth. Who doesn’t want twice the perks? Working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!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, we have an FSP opportunity to match your area of expertise.You will enjoy the best of both worlds—all the benefits that come along with our 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.Our 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.Our 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.In this role, the selected candidate will lead or support studies and be the operational point of contact for trial execution and deliverables. You will manage all Operation Activities including managing the Clinical Trial Team (CTT) and supporting clinical supplies planning. Responsible for operational deliverables in preparation for site ready, country allocation, and achievement of recruitment targets. Additional responsibilities include:Manages deployment and interactions with external vendors (e.g., IVRS, PRO)

Initiates planning for Investigator meeting and protocol training.

Plans and assesses protocol ancillary supplies

Completes trial set-up and maintains SPECTRUM

Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT

Initiates recruitment/retention planning & enrollment tracking

Responsible for tracking study related details (e.g., specimens, queries)

Oversees protocol training activities including IMs and CRAs training meetings

Ensures appropriate postings to investigative site portals

Point of escalation for study related operational issues

Responsible for operational details at Operational Reviews

Responsible for creating and maintaining project schedule and collaborating with Program Lead

Sets up and maintains Trial Master File (eTMF)

Ensures alignment of budget with protocol needs

Responsible for executing protocol within the budget

Responsible for risk assessment, mitigation planning and execution

Responsible for creating and maintaining ADI logs

Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group

Develops study related manuals (e.g., administrative binder, lab manuals)

Manages Emergency Unblinding (EUB) Call Center activities

Co-authors newsletters with CS

Approves contracts, invoice payments and change orders for vendors, as necessary

Responsible for end of study reconciliation (clinical & ancillary supplies)

Oversees all HQ close-out tasks

Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking

Supports CS activities as needed to achieve CTT deliverables

Interface with External Data Coordination and Data Management

Responsible for quality control and inspection readiness at all times

Education/Qualifications:BS/BA/MS/PhD with 7+ yrs clinical research experience

Experience:Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead Study Manager required

Proven ability to meet aggressive timelines

MS Project experience preferred

Excellent Excel and Power Point skills required

Excellent oral (including presentation) and written communication, computer/database management, and project management skills required

Must have experience managing oncology studies

Vacancy expired!

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