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Local Site Feasibility Specialist - Iqvia Biotech (Home-based)
IQVIA Holdings Inc.
Various Locations
IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we work in is cutting edge with therapies for un-met medical need.
We are currently looking for Local Site Feasibility Specialist's in:
- Germany
- Poland
- Netherlands
- Belgium
- Czech Republic
- Hungary
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Manage assigned opportunities / projects / programs for country and adhere to timelines and budget.
• Review site list for appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol.
• Identify potential new sites and develop effective local feasibility / Site Identification processes for assigned projects.
• Review site list for appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol.
• Has responsibility for leading the Site Identification effort on assigned projects within a key region/country of expertise
• Subject matter expert on the evaluation of a site and Principal Investigator’s (PI) credentials and appropriateness to participate in a clinical trial based on historical data and experience. This includes verifying the site and PI meet criteria as indicated in the Transfer of Knowledge meeting.
• Distribute, track, negotiate and review the Confidential Disclosure Agreements (CDAs) for Feasibility / Site Identification with assistance from Management / Legal as appropriate.
• Distribute, track and review Feasibility Questionnaires for Feasibility / Site Identification for completeness, site capability and suitability of investigators.
• Collect, review and reconcile country Feasibility / Site Identification data and check for completeness and correctness to meet timelines of proposal process and independent feasibility assessments.
• Maintain and update company information repositories and databases.
KNOWLEDGE, SKILLS & ABILITIES:
• 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.
• Ability to speak multiple languages is preferred.
• Manage assigned opportunities / projects / programs for country and adhere to timelines and budget.
• Review site list for appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol.
• Identify potential new sites and develop effective local feasibility / Site Identification processes for assigned projects.
• Review site list for appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol.
• Has responsibility for leading the Site Identification effort on assigned projects within a key region/country of expertise
• Subject matter expert on the evaluation of a site and Principal Investigator’s (PI) credentials and appropriateness to participate in a clinical trial based on historical data and experience. This includes verifying the site and PI meet criteria as indicated in the Transfer of Knowledge meeting.
• Distribute, track, negotiate and review the Confidential Disclosure Agreements (CDAs) for Feasibility / Site Identification with assistance from Management / Legal as appropriate.
• Distribute, track and review Feasibility Questionnaires for Feasibility / Site Identification for completeness, site capability and suitability of investigators.
• Collect, review and reconcile country Feasibility / Site Identification data and check for completeness and correctness to meet timelines of proposal process and independent feasibility assessments.
• Maintain and update company information repositories and databases.
KNOWLEDGE, SKILLS & ABILITIES:
• 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.
• Ability to speak multiple languages is preferred.
#LI-AP22
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
Job posted: 2021-04-19
