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Clinical Operations SpecialistRef: mc 23774

Salary:€30000 - €31000 per annum

Added:06 Dec 2018

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical Research

1.Study budget management. Responsible for evaluation and tracking of investigators fees (country level budget/Grant Plan) esti-mates per country and the negotiation of investigators fees and country related study costs. Support Clinical Project Manager (CPM) ensuring accurate planning, tracking and reporting of study budget. 2.Vendor and monitoring partner coordination. Support CPM in the set-up and coordination of third-party vendors (i.e. central lab, investigators' meeting organization) and monitoring partner, ensuring all information, documentation and material in place for study start. Responsible for effective and smooth workflow between study participants (i.e. third-party vendors and monitoring partner). Follow-up with vendors and monitoring partners on day-to-day operations (recruitment reports, delivery of study kits …). 3.Study logistics. Responsible for the set-up and maintenance of studies in Clinical Trial Management Systems (CTMS). Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF). Ensure availability of study material for monitoring partner/sites (i.e. IV bags, fridge, laptops, etc…) including tracking of rented material. Support (Sr.) CPM in meeting set-up, minutes, running reports from systems, draft study documentation. Support (Sr.) CPM in study start up, recruitment and close out activities as required. 4.Other Responsibilities. As applicable directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk as-sessment and timely issue resolution in alignment with Novartis global standard with local regulation requirement. As applicable support (Sr.) CPM in drug forecasting projections, keeping overview of drug availability at site and global level in collaboration with monitoring partner, drug supply management and other PLS functions. As applicable support (Sr.) CPM with compilation or study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated PLS, Novartis line functions and CRO Partners as required. Also if needed support (Sr.) CPM with all clinical studies onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions. Champion the implementation of operational changes and transitions as required.

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