Rosanda Kovacevic
Sydney
Summary
Dynamic Clinical Operations Manager with extensive experience managing regional teams and leading clinical operations, site engagement, and recruitment strategies while ensuring compliance with regulatory standards. Exhibits a strong ability in strategic planning and process optimization to enhance efficiency and deliver high-quality outcomes. Passionate about fostering cross-functional collaboration and building robust relationships, cultivating strong partnerships with internal teams and external experts to achieve operational excellence. Proficient in crafting tailored recruitment strategies, enhancing site engagement, and implementing innovative processes to optimize trial execution and streamline workflows. Committed to maintaining compliance and driving successful project delivery.
Overview
15
15
years of professional experience
Work History
Clinical Operations Manager
Abbvie Pty. Ltd
12.2017 - Current
- Managed teams of up to 15 members and oversaw the execution of up to 60 studies.
- Demonstrated leadership through effective people and talent management, spearheading various projects, and supporting cross-functional teams to achieve strategic goals.
- Ensured clinical trials were conducted in compliance with regulations and adhered to ICH GCP standards.
- Conducted feasibility assessments at country and site levels in collaboration with the global study team and local Medical Affairs.
- Led site engagements and feasibility assessments by coordinating with site staff and stakeholders to evaluate potential sites for study participation. Developed comprehensive feasibility assessments through detailed analysis of site capabilities, resources, and potential recruitment capacity. Fostered strong relationships with site teams to ensure alignment with study objectives and seamless integration into project timelines.
- Responsible for developing and executing site recruitment strategies to meet enrollment targets, with adjustments based on performance metrics analysis.
- Oversaw the daily activities, responsibilities, and performance evaluations of the Contract Research Organization (CRO) team to ensure alignment with project objectives.
- Collaborated with CRO Managers to develop and implement project plans, ensuring timely and efficient execution of deliverables.
- Coached and monitored CRAs, supporting their professional development.
- Engaged in global process improvement initiatives and fostered collaboration with stakeholders.
- Responsible for resourcing studies and ensuring monitors were appropriately assigned based on their experience and expertise.
- In the assigned Therapeutic Are, focused on building strong relationships and enhancing customer centricity. Leveraged influencing skills to drive initiatives and actively participated in industry conferences to stay informed and network effectively.
- Experience in running country-level operations, overseeing strategic planning and execution to ensure alignment with organizational objectives and regulatory requirements.
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
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
06-1991
Skills
- Resource Management
- Site Engagement Strategy
- Study Recruitment Strategy
- Cross- Functional Leadership
- Quality Improvement
- Process Implementation
- Strategic Planning
- Staff Development
- Coaching and Mentoring
- Project Management
- Talent management
- Leadership skills
Affiliations
- Energetic and lively, I live a balanced life focused on wellness, creativity, and exploring new foods
References
References available upon request.
Languages
Serbian
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
Nursing
School of Secondary Education
Bachelor of Biological Sciences -
University of Western Sydney
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