Kimberly Kreller
Strongsville
Summary
Talented Assistant Director with expertise in program management and special projects. Proficient in financial administration and training. Bringing [Number]-year track record of success in [Name] industry.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Associate Director, Clinical Safety
Medpace
Cleveland, OH
10.2024 - Current
- Oversee clinical safety case management and aggregate reporting responsibilities at a program level
- Maintain relationships with clients and internal stakeholders by providing expert safety knowledge
- Provide a safety review of clinical study documents, including protocols, study reports, and marketing application components
- Represent the clinical safety department in business development activities such as presentations to prospective Sponsors, Sponsor audits, and the generation of proposals, scope of work, and cost estimates
- Identify and manage process improvements, SOP updates, and training initiatives
- Mentor and develop clinical safety associates
- May be responsible for other projects and responsibilities as assigned
Sr. Clinical Safety Manager
Medpace
Cleveland, OH
04.2019 - 09.2024
- Oversaw the development of clinical safety, medical device, and post-marketing documents and set-up of safety database
- Reviewed safety reports (e.g., Serious Adverse Events, pregnancies, events of special interest, etc.) and queries to ensure consistency and quality throughout the trial/program
- Ensured that timelines for safety reports (i.e., expedited, periodic, and case reports) and Sponsor deliverables were met and tracked
- Oversaw the development and approval of periodic and annual safety reports (e.g., Development Safety Update Report, Periodic Safety Line Listings, Periodic Safety Update Report in Periodic Benefit Risk Evaluation Report format, and Periodic Adverse Drug Experience Report)
- Served as primary point of contact for Sponsor/marketing authorization holder for safety questions related to clinical trial, medical device, and post-marketing projects and issue escalation
Manager, Pharmacovigilance
Covance US (formerly Chiltern)
Princeton, NJ
03.2017 - 04.2019
- Provided budgetary, operational, and personnel leadership for a team of Pharmacovigilance staff
- Oversaw implementation of Chiltern Pharmacovigilance procedures
- Ensured that reported adverse events met applicable regulatory timelines
- Managed selection, training, development, and performance management for a team of Pharmacovigilance staff
- Assigned responsibilities to team members, in a manner that optimized team capability, delivered timely and accurate results, and supported the needs of the business
- Supported Business Development efforts with new and revised projects, interacted independently with Sponsors not directly involved in their projects and to assist in wider departmental tasks, and represented the department at face-to-face meetings
Project Manager, Early Phase Oncology
Research, US
Raleigh, NC
06.2015 - 02.2017
- Provided customer-focused leadership in managing early phase Oncology clinical trials
- Ensured the successful execution of all assigned projects, where success included on time, on-budget, and high quality/compliant project results that led to satisfied customers
- Maintained and evaluated project progress by maintaining timelines and other tracking/analysis tools
- Managed the executed contract and financial aspects of assigned projects
- Reviewed study budgets and expenses and ensured all study-related contractual and budgeting issues were upheld and performed
- Managed and tracked site payment issues as required and informed the Finance team of the need for customer invoicing
- Served as the primary liaison with customers to ensure study launch, conduct, and close-out according to the contractual agreement
- Served as the team leader for the project teams and acted as a liaison and facilitator between other Operations departments for project-related tasks and/or issues
- Managed projects ranging in size and complexity, from single service studies to full scope or multiple protocol projects
- Performed line management, responsible for assigned clinical staff
- Ensured studies were progressing according to internal and customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonisation guidelines to fulfill all federal and local regulations
- Facilitated team training in accordance with protocol and/or project requirements, including therapeutic, protocol-specific, and process training
- Reviewed protocols and draft Case Report Forms for consistency within each document
- Developed and maintained project plans for the study in accordance with SOPs and work instructions
- Assisted in the negotiation and contracting process with outside vendors
Clinical Project Manager
Clinical Research Management, US
Hinckley, OH
11.2010 - 06.2015
- Managed clinical trials for both the government and commercial sectors, including multicenter and international trials
- Served as the primary liaison for all customers, from study concept through development, implementation, and close-out
- Developed and managed project timelines and milestones within the assigned scope of work
- Defined, implemented, and maintained metrics for fiscal, operational, and quality management of clinical studies
- Led multidisciplinary study team members related to project management activities, including clinical science, pharmacovigilance, regulatory affairs, quality assurance, statistics, data management, and clinical monitoring during the clinical study lifecycle
- Participated in the design, writing, and review and approval of all project-related documents
- Contributed to site selection, resource identification, and negotiation for new studies
- Collaborated with project teams to define recruitment strategies and optimize subject recruitment
- Managed all company and contractual agreements for assigned studies
- Completed site agreements, contracts, and financial/site payment tracking
- Monitored verified and reconciled expenditure of budgeted funds
- Analyzed monthly financial forecasts and ensured planned revenue/profit was within targeted ranges
- Approved direct cost expenditures and monthly invoicing
- Prepared for and presented project updates and financial forecasts at monthly, quarterly, and annual meetings
- Participated in the preparation and presenting of bid-defense for commercial opportunities
- Served as technical lead or lead reviewer for Company Request for Proposals
- Developed both existing and new customer relationships and identified new source of revenue
- Interviewed and oriented new staff to the Clinical Operations Division
Director
Cleveland Clinic Foundation US
Cleveland, OH
11.2008 - 11.2010
- Performed research responsibilities and coordinated, planned, and supervised programs and projects, which promoted goodwill and fostered relationships in the community
- Worked to address cancer health disparities by establishing a Patient Navigation Program
- Acted as liaison/consultant for departments within the institute, the foundation, and outside institutions to connect community outreach programing with clinical research opportunities
- Established and implemented a strategic plan, project plans, short- and long-term organizational goals, and objectives for community outreach
- Developed and maintained cost budget to allocate overall cost estimates to individual tasks and provide financial analysis
- Identified, completed, and submitted grant funding opportunities
- Managed federally funded awards
- Built relations with potential donors, secured philanthropic dollars, and established contracts
Program Manager
Cleveland Clinic Foundation US
Cleveland, OH
09.2007 - 11.2008
- Performed comprehensive management of a regional multidisciplinary clinical research team to assure compliance with GCPs
- Developed and executed first Regional Research Integration Project Plan and Regional Research Business Review
- Initiated and conducted quality assurance efforts, which included performing internal auditing, maintaining corporate compliance, and researching billing/reimbursement regulations
- Involved in groundbreaking partnership with the Leukemia and Lymphoma Society
- Expanded research efforts throughout multiple health systems
Research Nurse Coordinator
Cleveland Clinic Foundation US
Cleveland, OH
03.2000 - 09.2007
- Expanded research efforts throughout multiple health systems
Clinical Nurse
Cleveland Clinic Foundation US
Cleveland, OH
02.1995 - 03.2000
Education
Bachelor of Science - Nursing
Kent State University
Kent, OH12-1994
Skills
- Microsoft Office applications
- Argus Safety Database
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
- Relationship building
Certification
Registered Nurse (RN) license, Ohio Board of Nursing
Timeline
Associate Director, Clinical Safety
Medpace
10.2024 - Current
Sr. Clinical Safety Manager
Medpace
04.2019 - 09.2024
Manager, Pharmacovigilance
Covance US (formerly Chiltern)
03.2017 - 04.2019
Project Manager, Early Phase Oncology
Research, US
06.2015 - 02.2017
Clinical Project Manager
Clinical Research Management, US
11.2010 - 06.2015
Director
Cleveland Clinic Foundation US
11.2008 - 11.2010
Program Manager
Cleveland Clinic Foundation US
09.2007 - 11.2008
Research Nurse Coordinator
Cleveland Clinic Foundation US
03.2000 - 09.2007
Clinical Nurse
Cleveland Clinic Foundation US
02.1995 - 03.2000
Bachelor of Science - Nursing
Kent State University