Site ID Svcs Specialist 2/Site ID Svcs Specialist 1
Posted on Dec 9, 2018 by IQVIA
The key responsibilities of this position will be to manage the CDA (confidentiality) process with the study teams, sponsors and sites for studies in SID.
Manage and lead activities associated with Feasibility and / or Site Identification for regional and / or country projects and / or programs. May be responsible for some or all of the following activities at any one time.
? Manage assigned opportunities / projects / programs for country or region and adhere to timelines and budget.
? Generate site list of appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol
? Coordinate collection and analysis of country / regional Feasibility / Site Identification information to meet timelines of proposal process and independent feasibility assessments
? Reconcile and interpret Feasibility / Site Identification data to provide country level assessments and recommendations for country site numbers, recruitment rates, timelines and screen failure rates
? Distribute, track, negotiate and review the Confidential Disclosure Agreements (CDAs) for Feasibility / Site Identification with assistance from Management / Legal department as appropriate
? Distribute, track and review Site Questionnaire Forms for Feasibility / Site Identification for completeness, site capability and suitability of investigators
? Manage the investigator database entry and quality, ensuring complete investigator and site information is captured, and monitor for duplicate entries
? Maintain and update company information repositories and databases
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Experience with study legal documents like confidentiality agreements, non-disclosure agreements or site contracts is a strong plus
? Sound knowledge of medical terminology, GCP, FDA regulations, and Drug Development process and procedures.
? Strong communication, organizational and interpersonal skills.
? Proficient in the use of Microsoft Office, Presentation skills and team training.
? Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
? Strong negotiation skills.
? Strong verbal and written communication including good command of English language
? Ability to handle multiple tasks with varying deadlines.
? Ability to maintain confidentiality.
? Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field, with 3 years? relevant experience including demonstrable experience in acting as the main local lead in studies or equivalent combination of education, training and experience.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'
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