CSL · 1 hour ago
Associate Director Site Mgmt & Oversight Lead (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$155K/yr - $183K/yr
12+ years expCSL is a global biotherapeutics leader focused on saving lives through innovative therapies. The Associate Director will lead one or more Therapeutic Areas, ensuring high-quality project timelines and operational oversight of clinical sites.
BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
Responsible for operational oversight of the site, site health and monitoring activities
Support QA audit and inspection planning, and implementation of CAPAs as needed
Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs
Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
Support 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
Build and maintain strong, trusted relationships with investigators and site staff – Face of CSL
Serve as the sponsor primary point of contacted for assigned studies
Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration
Collect feedback from sites and advocate for process simplification and burden reduction internally
Identify opportunities to improve study materials, and operational processes
Represent the 'voice of the site' in cross-functional discussions and initiatives
Provide local site intelligence to feasibility teams
Support site development
Qualification
Required
At minimum, bachelor's degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. (Other degrees and certifications considered if commensurate with related clinical research experience [e.g., diploma or associate degree RN, certified medical technologist])
A minimum of 12 years' relevant clinical research (or related) experience within the pharmaceutical industry
Previous experience in leading and managing a team of professional staff
A solid understanding of the drug development process, and specifically, each step within the clinical trial process
Experience in site management and monitoring and overseeing large and/or complex global clinical trials
Robust budget forecasting and management experience
Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Demonstrated ability to lead teams and work in a fast-paced team environment
Demonstrated ability to oversee vendors and CROs
Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment
Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of ‘best practice'
Excellent interpersonal and decision-making skills
Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives
Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report
Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards
Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge
Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills
Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs
Excellent written and oral communication skills and maintains computer literacy in appropriate software
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
Pharma Letter
2026-01-03
2025-10-29
Company data provided by crunchbase