Senior Study Manager, Infectious Disease and Vaccines
Senior Study Manager - Infectious Disease and Vaccines
Remote in the USA or Canada
Why 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, 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 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
- BS/BA/MS/PhD with 7+ yrs clinical research 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
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