IQVIA
Pharmaceutical
Assoc.ClinicalProjectManagerSponsorDedicated
“Assoc. Clinical Project Manager - Sponsor Dedicated at IQVIA. Skills: Clinical trial management, Sponsor SOPs, ICH-GCP. Provide operational oversight of assigned project(s). Manage end-to-end project management from start-up through to”
What You'll Achieve.
Ensure local/country team is tracking project progress; Ensure target enrollment will be met; Drive study compliance; Analyze trial progress
Industry & Context.
Risk management; Contingency planning
Occasional overnight stay, Willingness to travel
What They're Looking For.
Must Have
BAS degree, Degree in a health or science related field, Minimum of 1 years of local/regional trial management experience in the pharmaceutical industry or CRO, Previous experience as Clinical Research Associate, Oncology therapeutic area experience, Working knowledge of ICH-GCP, Working knowledge of company standard operating procedures, Working knowledge of local laws and regulations, Working knowledge of assigned protocols, Working knowledge of associated protocol specific procedures, IT skills in appropriate software and company systems, Proficient in speaking and writing the country language, Proficient in speaking and writing English
Nice to Have
Willingness to travel with occasional overnight stay away from home according to business needs
What You'll Do.
Provide operational oversight of assigned project(s)
Manage end-to-end project management from start-up through to
Adhere to applicable Sponsor SOPs
Prepare or contribute to high level budget estimate
Prepare detailed budget proposal
Ensure overall contract management
Review external service provider (ESP) contracts
Approve external service provider (ESP) contracts
Approve change orders
Ensure services are delivered per contract
Act as primary company contact for assigned trial
Ensure local/country team is tracking project progress against
Monitor patient recruitment rate to ensure target enrollment
Develop local trial specific procedures and tools
Develop recruitment planning
Develop contingency and risk management
Develop budget forecasting
Drive study compliance
Maintain trial management systems
Update trial management systems
Use management reports to analyze trial progress
Participate in preparation for Health Authority (HA) inspections
Participate in conduct of Health Authority (HA) inspections
Participate in preparation for internal Quality Assurance audits
Participate in conduct of internal Quality Assurance audits
Escalate corrective and preventive actions (CAPA) to GTL
Communicate study progress to study management teams
Communicate study issues to study management teams
Communicate study progress to business partners
Communicate study issues to business partners
Follow-up other lateral processes
Support start-up/reg activities
Support and negotiate country and site budgets
Contribute to patient understanding of protocol
Contribute to patient safety
Contribute to the review of country specific informed
Review site specific informed consent forms
Manage site specific informed consent forms
How You'll Work.
Team & Collaboration
Local/country team; Study management teams; Business partners; Finance team
Communication Scope
Written communication; Oral communication
Process & Methodology
Project management, Trial management, Budget management, Contract management, Risk management, Timeline management, Enrollment management
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