Director, Regional Head – Site Management & Oversight, Europe
CSL
full-time
Posted on:
Location Type: Remote
Location: Spain
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Job Level
Tech Stack
About the role
- Provides strategic leadership for clinical site operations
- Ensures effective conduct and supervision of site management activities and oversight for clinical programs
- Acts as the strategic link between therapeutic areas and investigator sites
- Leads both permanent and functional service-provider site management teams
- Cultivates strong strategic partnerships with service providers and CROs
- Develops strong and lasting relationships within Medical Affairs at the regional level and with HCPs
- Responsible for operational oversight of the site, site health and monitoring activities
- Supports QA audit and inspection planning, and implementation of CAPAs as needed
- Identifies and proactively mitigates site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs
- Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
- Supports sites in understanding study expectations, timelines, and required deliverables
- Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
- Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs
- Builds and maintains strong, trusted relationships with investigators and site staff
- Serves as the sponsor primary point of contact for assigned studies
- Understands site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration
- Collects feedback from sites and advocates for process simplification and burden reduction internally
- Identifies opportunities to improve study materials, and operational processes
Requirements
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology
- 12 years+ relevant clinical research experience within the pharmaceutical industry
- Experience in leading and managing a professional team with strong experience in site management, monitoring and overseeing large and/or complex global clinical trials
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process
- Robust budget forecasting and management experience
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
- Proven experience in overseeing vendors and CROs
- Must have experience as a mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
- Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
- Must have excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchsite managementmonitoringbudget forecastingdrug development processclinical trial processICH guidelinesGCPvendor oversightclinical project management
Soft Skills
strategic leadershiprelationship buildingmentoringcoachingcommunicationproblem-solvingrisk mitigationcollaborationteam managementprocess improvement
Certifications
Bachelor’s degree in life scienceBachelor’s degree in nursingBachelor’s degree in pharmacyBachelor’s degree in medical laboratory technology