Karla Watson
Clinical Trial Manager
Summary
Accomplished Clinical Trial Manager with a proven track record at Thermo Fisher and 6+ years experience in clinical trials, directing multinational clinical trials with a focus on efficiency and patient safety. Skilled in ICH-GCP Guidelines and fostering team collaboration, demonstrated through successful site activations and regulatory compliance. Experience managing phase II, phase III and phase IV trails across a multitude of therapeutic areas including Infections/Respiratory diseases, Digestive and Musculoskeletal disorders, and Hematology/Oncology.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Trial Manager
Thermo Fisher
10.2023 - Current
- Directed a team of 10+ CRAs across 5+ countries to manage infections and respiratory disease trials, including interim analysis and study closures.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Implemented RBQM processes which leveraged technology to identify potential issues and allow teams to concentrate on high value tasks with the most potential to impact patient safety
- Drafted and implemented monitoring plans and other study documentation required for the effective execution of the trial
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
- Managed study budget and resource allocation proactively, preventing cost overruns across concurrent trials.
Senior Clinical Research Associate II
PPD/Thermo Fisher
01.2023 - 09.2023
- Successfully oversaw 5+ site activations within 6 months, while ensuring compliance with GCP and ethical standards.
- Managed 15+ sites across 4+ protocols, to ensure study and regulatory compliance while maintaining patient safety and data integrity
- Participated in a successful Sponsor GCP audit with crossfunctional teams
- Performed critical role in developing risk mitigation strategies that decreased audit findings
- Fostered strong relationships with site personnel and internal team members, enhancing communications and study progress.
- Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
- Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
Senior Clinical Research Associate I
PPD
11.2021 - 12.2022
- Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
- Increased the accuracy of study data by implementing robust quality control measures during data review and analysis phases.
- Synthesized and utilized key information from proposals, technical reports and publications to achieve objectives.
- Conducted performance assessment visits for junior and senior CRAs to assess their abilities and identify training gaps and conducted training of junior staff on various aspects of the CRA role.
Clinical Research Associate II
PPD
02.2021 - 11.2021
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Conducted meetings with sponsor representatives to discuss clinical study developments.
- Reviewed referral information and kept track of intakes from various referral sources.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Participated in a regulatory inspection, and worked across necessary departments, which resulted in no findings (critical, major or minor), this resulted in my successful promotion to Senior CRA I.
Clinical Research Associate
ICON Clinical Research
04.2019 - 01.2021
- Performed both remote and onsite interim monitoring and close out visits with both 100% and reduced SDV.
- Communicate with site staff, principal investigator and study teams to facilitate daily trial activities and comply with research protocols.
- Conduct Source Data Review (SDR and Source Data Verification (SDV) to ensure accuracy of source documents including ICFs, case report forms, clinical study materials and investigational product logs.
- Author and submit interim monitoring visit (IMV) reports with CTMS and site follow up letters to the sites in order to appropriately track and share action items.
- Supported development and delivery of department training to maximize success of clinical research.
- Reviewed and assisted with the development of site SOPs to accurately document and streamline site processes.
In-House CRA
ICON Clinical Research
04.2018 - 03.2019
- Conducted regular contacts with study sites to support sites execution of their study responsibilities.
- Monitored site performance and implemented action plans for sites not meeting expectations, in conjunction with the CRA and CTM
- Assisted CRAs with preparation for site visits (i.e running reports, QC of files (checking for missing documents), resolving action items from previous visits), Perform Case Report Form review, query generation and resolution against established data review guidelines
- Liaised with CRAs and project leads to effectively resolve study-related issues.
- Communicated with vendors to deliver appropriate clinical supplies to sites and meet ongoing operational demands.
Education
Honors Bachelor of Science - Biochemistry
University of Pretoria
South Africa 04.2001 -
Bachelor of Science - Biochemistry, South Africa
University of Pretoria
South Africa 04.2001 -
Skills
- ICH-GCP Guidelines
- Clinical Trial Management
- Metrics Management
- Site Monitoring
- Patient Recruitment
- Data Management
- Regulatory Compliance
- Study systems (CTMS, IVRS/IWRS, eTMF and EDC)
Certification
Project Management Foundations
Timeline
Clinical Trial Manager
Thermo Fisher
10.2023 - Current
Senior Clinical Research Associate II
PPD/Thermo Fisher
01.2023 - 09.2023
Project Management Foundations
04-2022
Senior Clinical Research Associate I
PPD
11.2021 - 12.2022
Clinical Research Associate II
PPD
02.2021 - 11.2021
Clinical Research Associate
ICON Clinical Research
04.2019 - 01.2021
In-House CRA
ICON Clinical Research
04.2018 - 03.2019
Honors Bachelor of Science - Biochemistry
University of Pretoria
04.2001 -
Bachelor of Science - Biochemistry, South Africa
University of Pretoria
04.2001 -
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