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The Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out activities. This position will perform required job dutie...
Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study tim...
This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.
Manages clinical operational plan, and incorporates the study and scientific plan. Works closely with the project team to develop the clinical trial protocol and design all associated clinical forms...
In depth knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines...
This role drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and...
Develops full suite of planning tools for each clinical trial, including Study Oversight Plan, Clinical Monitoring Plan, enrollment plan, communication plan, contingency plan, start up and closure pla...
Acts as the subject matter expert and primary point of contact for relevant functional stakeholders on IR activities and deliverables to provide real-time, proactive advice and guidance to drive towar...
Responsible for the review and oversight of tasks in study monitoring plans for operations and all operational activities associated with clinical trials. Provides leadership for ClinOps related issue...
Experience developing trial plans including developing plan for site monitoring, site selection, and clinical supplies management Excellent communication skills to effectively disseminate information...
Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with cli...
In coordination with other department heads, implement process improvements geared toward the development of accurate clinical trial budgets, the maximization of sponsor revenue and the adherence of a...