clinical operations lead in new delhi

posted
contact
randstad india
position type
temporary
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posted
location
new delhi
function
Other
position type
temporary
experience
15
reference number
53722
contact
randstad india

job description

clinical operations lead in new delhi

Approximately 15+ years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinicaltrials within quality, timeline, and budget expectations (or extensive experiencewithin either) • Prior investigator site and/or monitoring experience is advantageous • Deep understanding of clinical development within one or more Phases oftrials (Phase I, II, III, IV) and a working understanding of cross functional drug development. • Scientific learning agility to quickly develop a sound working knowledge ofnew therapeutic areas. • Ability to establish operational plans and support the CRO in the executionof the plans. • Requires a balance of scientific and operational/project management and team leadership expertise. • Must be able to build effective relationships across and up and down theorganization.ResponsibilitiesDevelop scientifically robust, operationally feasible and clear protocolconcepts and protocols, and feasible protocols and robust data monitoring plans • Leverage appropriate on-going data review to identify and mitigate patientsafety, study design, data integrity or study conduct issues • Ensure all operational aspects support end point integrity and datavalidity. • Able to influence MD on clinical study/program direction based on changinginternal and external landscapes within phase, disease, or therapeutic area; able tothink strategically to best position a study within the current Clinical DevelopmentPlan • Contributing to a clinical development plan within a program moving into anew or subdivision of a current indication. • Building a rich knowledge of specific Area(s) of Expertise within a phase. • Utilizing operational expertise and scientific assessment to evaluate studyfeasibility: assess end point measurement options and ensure the successful execution of study(ies).

skills

project management, clinical operations