Associate Director Site Mgmt & Oversight Lead (Remote)

This individual will lead one or more Therapeutic Areas (TA) working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality. Position possible to be considered remotely due to travel need.

Clinical Oversight & Compliance

• 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

• 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.