Kristine Michelle Tinsley
Kyle,Texas
Overview
23
23
years of professional experience
Work History
Project Manager IV
Fortrea
07.2023 - Current
- Oversees and manages domestic, regional and/or international clinical trials conducted at Fortrea Clinical research sites, external sites, and data services projects. Projects generally include full service including multiple moderately complex trials managing multiple vendors and external sites for trials of moderate to high financial value, and may consist of serving in a program oversight role. Primary client contact and responsible for the facilitation of communication, managing client expectations, and building business relationships.
- Responsibilities typically include managing scope of project and project components, budgets, timelines, and quality guidelines thereby ensuring that expectations are met while identifying and mitigating risks. Responsible for managing the project team in a matrix environment. May also contribute to strategic relationships by monitoring and reporting Key Performance Indicators (KPI), and may assist in the development of KPI. Using detailed knowledge of clinical development, may lead bid defense and other business development activities.
- Formerly Labcorp
Project Manager IV
Labcorp
09.2022 - 07.2023
- Oversaw and managed domestic, regional and/or international clinical trials conducted at Labcorp Clinical research sites, external sites, and data services projects. Projects generally included full service including multiple moderately complex trials managing multiple vendors and external sites for trials of moderate to high financial value, and may have consisted of serving in a program oversight role. Primary client contact and responsible for the facilitation of communication, managing client expectations, and building business relationships.
- Responsibilities typically included managing scope of project and project components, budgets, timelines, and quality guidelines thereby ensuring that expectations were met while identifying and mitigating risks. Responsible for managing the project team in a matrix environment. May have also contributed to strategic relationships by monitoring and reporting Key Performance Indicators (KPI), and may have assisted in the development of KPI. Using detailed knowledge of clinical development, may have led bid defense and other business development activities.
Project Manager II
Syneos Health
08.2021 - 09.2022
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP's, and regulatory requirements. Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
- Lead project team to ensure quality, timelines and budget management.
- Accountable for the financial performance of each project.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements.
- Accountable for all project deliverables for each project assigned.
- Responsible for quality and completeness of TMF for assigned projects.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
- Oversight for development and implementation of project plans.
- Plan, coordinate and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Develops strong relationships with current clients to generate new and/or add-on business for the future.
- May participate in bid defense meetings where presented as potential project manager.
- May be required to line manage other project management team members and clinical monitoring staff.
Project Manager
PPD Early Development Services
09.2020 - 07.2021
- Serves as the primary contact between the sponsor and the organization at the project level.
- Ensures that escalation pathways are adhered to internally and externally.
- On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor or subset of delivery).
- Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of out-of-scope activity, drive the Con Mod process/negotiations and team execution to timelines.
- Establishes, communicates, and manages customer expectations to achieve optimal delivery during the project.
- Drives risk identification early on and Issue Resolution at the project level.
- Holds Kick-Off meetings, internal team, and sponsor team meetings and ensures meeting minutes are completed and sent to the team in a timely manner.
- Creates study plans with sponsor input: eTMF plan, Communication Plan, Project Management Plan, Actions/Decisions Log.
- Follows study through eTMF delivery following department uploads and eTMF QC.
- Manages CRA activities, such as site visit schedule and delivery of monitor reports.
Sr. Manager Study Conduct
Worldwide Clinical Trials
San Antonio, TX
09.2010 - 09.2020
- Responsible for planning staffing needs for clinical staff as well as overseeing the proper and efficient management of all ongoing clinical trials.
- Hires, trains, schedules and supervises clinical staff.
- Develops staff working relationships, communication skills, and encourages team members to seek solutions and forecast potential problems.
- Works closely with other departments to organize and plan clinical trials in new therapeutic areas or new study procedures.
- Oversees all trials running simultaneously to ensure they are conducted and enrolled in the most efficient manner.
- Performs annual performance reviews on direct reports as well as ongoing performance counseling as required.
- Pre-study site visits, SIVs, all other study related visits by CRAs and Sponsor representatives.
- Assures quality and completeness of source data and case report forms.
- Ensures study timelines are met and database locks are completed per sponsor timelines.
- San Antonio, TX
Supervisor, Project Management
Covance Global Clinical Pharmacology
Austin, TX
07.2007 - 05.2010
- Responsible for the overall supervision, administration, and organization of the Project Management Department, which included a staff of study managers, study coordinators, and a regulatory specialist.
- Developed strategies for efficient trial conduct, data collection/chart management, patient management, and safety monitoring. Additionally, coordinated efforts interdepartmentally to accomplish these strategies.
- Ensured that appropriate training and career development took place so that staff would adequately perform their duties to the forecasted workload and develop to their fullest career potential.
- Continuously seeked out new and better ideas, driving best practices and benchmarking externally.
- Continuously provided employees feedback regarding performance through individual monthly meetings and yearly performance reviews. Created departmental and individual goals to maximize process improvement and performance.
- Reviewed and revised clinical and vendor budgets for accuracy and ensured adequate cost containment practices. Executed local vendor contracts and ensured payment within agreed upon timelines.
- Completed RFI forms and clinic feasibility assessments.
- Austin, TX
Clinical Study Manager
Covance Global Clinical Pharmacology
Austin, TX
10.2004 - 07.2007
- Interfaced with representatives of the pharmaceutical industry as well as clinical research staff and research participants and patients.
- Overall management responsibility of allocated trials from IRB submission through study closeout.
- Worked in collaboration with program managers, created trial timelines and ensured exact follow through by team members.
- Coordinated services with outside vendors such clinical laboratories and cardiac services and reviewed budgets and contracts for those vendor services.
- Hosted monitors and clients during site visits and maintained a positive relationship throughout the trial. Acted as the primary liaison between patients, staff and the client company.
- Ensured enrollment of qualified subjects into trials in the timeline specified by the client company.
- Ensured Independent Review Board was notified of protocol deviations, serious adverse events, and other unanticipated events.
- Served as Lead Clinical Study Manager for multi-site trials across the US and managed several trials at one time.
- Delivered trial status updates to clients through constant communication and led formal site/client meetings to discuss trial safety and timelines.
- Austin, TX
Clinical Research Team Coordinator
PPD Inc
Austin, TX
09.2003 - 10.2004
- Reviewed study source documents for correctness and adherence with WPD's, GCP's, and SOP's.
- Responsible for entering study data into case report forms in both paper and electronic forms.
- Maintained a professional relationship while working closely with the sponsor company representatives.
- Archived source documents upon study completion.
- Assisted other team members in study recruitment and conduction as needed.
- Austin, TX
Timeline
Project Manager IV
Fortrea
07.2023 - Current
Project Manager IV
Labcorp
09.2022 - 07.2023
Project Manager II
Syneos Health
08.2021 - 09.2022
Project Manager
PPD Early Development Services
09.2020 - 07.2021
Sr. Manager Study Conduct
Worldwide Clinical Trials
09.2010 - 09.2020
Supervisor, Project Management
Covance Global Clinical Pharmacology
07.2007 - 05.2010
Clinical Study Manager
Covance Global Clinical Pharmacology
10.2004 - 07.2007
Clinical Research Team Coordinator
PPD Inc
09.2003 - 10.2004