Rosanda Kovacevic
Sydney,NSW
Summary
Dynamic Clinical Operations Manager with extensive experience in leading clinical operations and ensuring compliance with regulatory standards. Expertise in strategic planning, process improvement, and team leadership, with a proven track record of enhancing efficiency in clinical settings while delivering high-quality outcomes. Adept at collaborating with cross-functional teams to align on critical success factors and engaging with external experts to leverage insights for operational excellence.
Overview
15
15
years of professional experience
Work History
Clinical Operations Manager
Abbvie Pty. Ltd
12.2017 - Current
- Executed site-related activities in the Therapeutic Area and managed team resources aligned with research goals.
- Conducted feasibility assessments at country and site levels in collaboration with the global study team.
- Achieved effective Site Management and Monitoring, maintaining accurate clinical trials management system data.
- Ensured compliance with regulations and prepared for audits, contributing to CAPA efforts.
- Coached and monitored CRAs, supporting their professional development.
- Served as the primary country contact for the global study team, providing timely updates.
- Engaged in global process improvement initiatives and fostered collaboration with stakeholders.
Senior Clinical Research Associate
Abbvie Pty Ltd
05.2017 - 11.2017
- Managed the end-to-end execution of five clinical projects, overseeing sites and teams.
- Tracked regulatory submissions, recruitment, and data management while resolving queries.
- Developed tailored subject recruitment plans to enhance efforts at each site.
- Ensured clear communication for project unity and conducted site selection and visits.
- Collaborated with study team members and contributed to the design of study tools.
- Provided progress reports to management and delivered training to ensure site readiness.
- Evaluated site compliance with protocols and maintained thorough documentation.
- Mentored new clinical staff through co-monitoring and site visit.
Senior Clinical Research Associate
IQVIA
10.2013 - 05.2017
- This role had comparable responsibilities as SCRA at Abbvie.
Clinical Research Associate II
IQVIA
Sydney , NSW
04.2011 - 09.2013
- This role was a junior role relative to the SCRA role, with a focus on foundational skills and supporting team initiatives.
Clinical Research Associate I
Paraxel
02.2010 - 03.2011
- This role was a junior role relative to the SCRA role, with a focus on foundational skills and supporting team initiatives.
Education
Bachelor of Biological Sciences -
University of Western Sydney
01-2009
Nursing
School of Secondary Education
Zadar, Croatia 06-1991
Skills
- Resource Management
- Continuous Improvement
- Quality Improvement
- Process Implementation
- Strategic Planning
- Quality Oversight
- Staff Development
- Coaching and Mentoring
- Project Management
- Talent management
- Change Implementation
- Leadership skills
Affiliations
A dynamic individual with zest for life I embrace holistic lifestyle that combines wellness, creativity and culinary exploration.
References
References available upon request.
Timeline
Clinical Operations Manager
Abbvie Pty. Ltd
12.2017 - Current
Senior Clinical Research Associate
Abbvie Pty Ltd
05.2017 - 11.2017
Senior Clinical Research Associate
IQVIA
10.2013 - 05.2017
Clinical Research Associate II
IQVIA
04.2011 - 09.2013
Clinical Research Associate I
Paraxel
02.2010 - 03.2011
Bachelor of Biological Sciences -
University of Western Sydney
Nursing
School of Secondary Education
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