IQVIA
ClinicalTrialManager
“Clinical Trial Manager at IQVIA. Skills: Clinical Project Management, operational oversight, end-to-end project management, contract management, study compliance, trial management systems, Health Authority (HA) inspections, Quality Assurance audits, corrective and preventive actions (CAPA), site level recruitment strategy, patient safety, informed consent. management of a clinical trial (s) in a local level. operational oversight of assigned project(s) at the local level for end-to-end project m”
What You'll Achieve.
monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries; achieve clinical research target
Industry & Context.
decision-making
Willingness to travel with occasional overnight stay away from home according to business needs
What They're Looking For.
Must Have
BAS degree, Degree in a health or science related field, Minimum of 2 years of local/regional trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate, working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures, IT skills in appropriate software and company systems, Excellent decision-making and string financial management skills, Proficient in speaking and writing the country language and English
Nice to Have
Specific therapeutic area experience may be required depending on the position
What You'll Do.
management of a clinical trial (s) in a local level
operational oversight of assigned project(s) at the local level for end-to-end project management from start-up through to closeout activities
adhere to applicable Sponsor SOPs
codes of Good Clinical Practice (GCP)
local regulatory requirements
Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal
Ensures overall contract management
including review and approval of external service provider (ESP) contracts
change orders and ensures services are delivered per contract
Act as primary company contact for assigned trial at the country level
ensures local/country team is tracking project progress against planned timelines
monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries
development of local trial specific procedures and tools
contingency and risk management
and budget forecasting
Drive study compliance by maintaining and updating trial management systems
using study tools and management reports available to analyze trial progress
Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits
Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans
communicates study progress and issues to study management teams and business partners
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates
reviewing and managing site specific informed consent forms in accordance with SOPs
other procedural documents and applicable regulations
How You'll Work.
Team & Collaboration
Act as primary company contact for assigned trial at the country level; ensures local/country team is tracking project progress against planned timelines; Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas; communicates study progress and issues to study management teams and business partners
Communication Scope
Proficient in speaking and writing the country language and English; Good written and oral communication skills
Process & Methodology
Clinical Project Management, end-to-end project management, project progress against planned timelines, recruitment planning, contingency and risk management, budget forecasting, study compliance, trial management systems, Health Authority (HA) inspections, Quality Assurance audits, corrective and preventive actions (CAPA)
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