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.
Study Delivery Support
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
Site Relationship & Engagement
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
Continuous Improvement & Site Experience
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
Feasibility & Site Selection
Provide local site intelligence to feasibility teams
Support site development
Qualifications and Experience Requirements
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.
The expected base salary range for this position at hiring is $155,000 - $183,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our 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
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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