Shruti Sharma

Informed Consent Form (Icf) Lead-global Services @IQVIA

Durham, NC, US

Responsible to oversee the overall process of ICF development and associated project/study team activities, Manage / author development and roll out of project instructions (global and country), templates, and supporting documentation including training materials to enable ICF development at master / country level.Sponsor-facing role; establishing and maintaining strong relationships with key Sponsor team members at study/program level-Negotiating the process for ICF delivery, leading discussions on ICF timeline planning-Acting as a point of escalation within the project or at the client levelCreation of Master (study-level) ICFs and oversight of Master and Country ICF development and quality for assigned studies in line with ICH E6(R2) GCP for start-up and maintenance of Phase clinical trials.Review, establish and agree on project planning and project timelines with sponsor and teamReview Informed Consent Form (ICF) for completeness and accuracyVerify ICFs against the study protocolSupport team of ICF specialists in resolving their enquiries and provide cross-functional training and support as required