Global Delivery Manager
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Bulgaria
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About the role
- Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.
- SM works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival.
- Focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP).
- Works cross-functionally, with internal and external partners, on clinical study management activities, for in-house and outsourced studies across all phases and therapeutic areas.
- Responsible for monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives.
Requirements
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical research.
- 1-2 years working as an Associate Project Manager within a CRO or Pharma setting.
- Vendor management experience.
- Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
- Well familiar with key systems used in clinical trial delivery.
- Experience in using Trial Master File industry accepted standard.
- Strong project management skills (preferably with analytical / financial skills) and good leadership skills.
- Excellent verbal and written communication in English.
- Excellent communication and relationship building skills, including external service provider management skills.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchproject managementvendor managementstudy setupstudy archivalrisk managementeTMF managementanalytical skillsfinancial skillsclinical study delivery process
Soft skills
leadershipcommunicationrelationship buildingproblem solvingcollaborationcross-functional teamworkescalation managementorganizational skillsinterpersonal skillsadaptability
Certifications
Bachelor's degreeadvanced degree (preferred)ICH-GCP certification