CSL

Director, Regional Head Site Management & Oversight, Europe

CSL

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Provides strategic leadership for clinical site operations, ensuring effective conduct and supervision of site management activities and oversight for clinical programs within the assigned region.
  • Ensures alignment with overall strategy, adherence to international regulatory standards, and delivery within agreed timelines and budget.
  • Acts as the strategic link between therapeutic areas and investigator sites, ensuring high-quality execution of clinical programs.
  • Leads both permanent and functional service-provider site management teams while cultivating strong strategic partnerships with service providers and CROs.
  • Develops strong relationships within Medical Affairs at the regional level and with HCPs.
  • Responsible for operational oversight of the site, site health and monitoring activities.
  • Support 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.
  • Represents the “voice of the site” in cross-functional discussions and initiatives.
  • Provides local site intelligence to feasibility teams and supports site development.

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
  • For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
  • You Belong at CSL
  • At CSL, Inclusion and Belonging is at the core of our mission and who we are.
  • It fuels our innovation day in and day out.
  • By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
  • To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical researchsite managementmonitoringbudget forecastingdrug development processICH guidelinesGCPclinical trial processvendor 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