Donna Walters Email and Phone Number
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I am a senior clinical operations professional with demonstrated experience delivering consistent results, motivating teams, minimizing risk, and streamlining operations in pharmaceutical and clinical trials environments. I utilize business strategies and planning and management tools to drive change and create value. I have expertise in risk management and strategic operations with a consistent record in tackling strategic challenges and establishing strong team cultures and communicating across all levels. Specific success in leading clinical programs, clinical operations, project management, process and procedure mapping and clinical documentation support.
Kardigan
View- Website:
- kardigan.bio
- Employees:
- 108
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Sr. Director, Clinical Quality AssuranceKardiganNew York, Ny, Us
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Sr. Director, Clinical Quality AssuranceStealth Mode Biotech Nov 2024 - Present• Led GCP/GLP/GVP quality and compliance efforts.• Provide risk-based guidance and oversight for non-clinical and clinical studies.• Collaborate with R&D functions to ensure strategic alignment and quality assurance. -
Sr. Director, Qms Process Management & OptimizationBristol Myers Squibb Jul 2020 - Feb 2024Lawrenceville, New Jersey, United States -
Director, Controlled Procedural Documents (Quality Assurance And Compliance)Covance Apr 2019 - Jul 2020 -
Associate Director, Regulatory Policy, Compliance And StandardsCovance May 2015 - Jul 2020Princeton, NjDepartment responsible for the creation, revision, and maintenance of cross-functional clinical controlled documents, based on international regulations and guidelines and Covance strategies, goals, and standards. • Monitors internal and external notifications of changes to regulations or business processes and where necessary, proactively facilitates the initiation/revision of company procedures• Collaborate with cross-functional subject matter experts to design and document processes, develop associated controlled documents, and review and revise processes and supporting documentation, when appropriate• Establish and monitor processes to maintain currency and accuracy of best practices• Support global inspection readiness, client audits, and regulatory inspections, as needed• Contribute to the development, maintenance, revision and trending of metrics for Regulatory Compliance, Policy and Standards• Prioritize and manage resources to execute team projects, ensuring that the work is performed and completed on time, within specifications, and budget• Manages and supervises the Standards staff within the Regulatory Compliance, Policy and Standards function, including scheduling/delegating work, conducting performance review, participating in interviewing/hiring decisions and providing recommendations for pay/promotion decision.• Contributes to the creation and implementation of training and development for Standards staff
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Sr. Manager, RdcmAllergan Mar 2013 - Dec 2014Bridgewater, NjBuild out and manage Bridgewater, NJ staff of Clinical Service Specialists who perform global clinical site initiation activities, including obtaining and negotiation of informed consent, clinical trial agreements and regulatory documents. Assigns workload and priority to staff. Interfaces with representatives from Global Development Operations (GDO) to implement strategy for study initiation according to approved scope, timelines, internal process and regulations. Provides leadership to staff on metrics development and implementation. Ensures timely approval of site documentation for release of Clinical Supplies Shipments. Provides oversight for negotiations of clinical trial agreements. Ensures all required documentation is properly executed, received in house and filed appropriately. Responsible for leadership liaison to key leaders within the GDO operations team• Hire, train, manage performance of staff • Liaison for Contract Research Organization (CRO) sourcing team• Implementation of quality, efficient and consistent approach to carry out department tasks• Ensure compliance with all relevant regulations for global clinical trials• Development and application of departmental performance metrics -
Manager, Project PlanningKyowa Hakko Kirin Pharma Inc Apr 2011 - Feb 2013. Lead project management efforts for multiple oncology and non-oncology programs; lead Company efforts to establish suitable trial/program metrics, develop effective reporting dashboards for US and Headquarters management. Directly communicate project needs, timelines, and results to Project Leads at Headquarters in Tokyo. Work with Clinical Development Clinical Leads and Global Project Teams to establish and maintain up to date project plans and clinical development plans for each compound to ensure timely completion of protocols and filings in accordance with Headquarters mandates. Maintain program risk and issues and work to mitigate any potential impacts to the programs.
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Director, Document Managment And Trial RegistrationMerck Feb 2006 - Aug 2010Directed the department in global business and operational development processes associated with the essential document processing, informed consent template development, authoring and site negotiations, maintenance of trial master file, and clinical trial registry and reporting across all therapeutic areas. -
Associate Director, Medical Program Documentation Specialist (Mpds) /Manager, MpdsMerck 2002 - 2006Directed the activities of the Managers and Medical Documentation Specialists, Administrative Associates, and contractors in the planning, execution, and control of clinical trials as it relates to study start-up/ initiation activities (essential document collection, informed consent negotiations, IRB relationships, CRO relationships), creation of initial and subsequent regulatory packages, and Clinical Study Report appendix collation.
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Clinical Associate/ Sr. Medical Program Coordinator/Medical Program CoordinatorMerck 1991 - 2002Overall project management of clinical trials in assigned therapeutic areas.l Managed protocol development, project planning, case report form development, data review, study initiation, CSR writing, staff management, CRO oversight, training and audit resolution.
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Medical Research AssociateSchering-Plough Research Institute 1989 - 1991Overall project management of clinical trials in assigned therapeutic areas of OTC/Women's Health/Metabolism. l Managed protocol development, project planning, case report form development, data review, study initiation, CSR writing, staff management, site monitoring, training and audit resolution. -
Clinical Research AssociateJohnson & Johnson 1984 - 1989Overall project management of clinical trials in Dermatology. l Managed protocol development, case report form development, data review, study initiation, site monitoring, training and audit resolution.
Donna Walters Skills
Donna Walters Education Details
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Biology, General
Frequently Asked Questions about Donna Walters
What company does Donna Walters work for?
Donna Walters works for Kardigan
What is Donna Walters's role at the current company?
Donna Walters's current role is Sr. Director, Clinical Quality Assurance.
What is Donna Walters's email address?
Donna Walters's email address is dj****@****ine.net
What is Donna Walters's direct phone number?
Donna Walters's direct phone number is (609) 452*****
What schools did Donna Walters attend?
Donna Walters attended University Of Delaware.
What are some of Donna Walters's interests?
Donna Walters has interest in Children, Crafting, Education, Scuba Diving, Horseback Riding, Disaster And Humanitarian Relief, Animal Welfare, Arts And Culture.
What skills is Donna Walters known for?
Donna Walters has skills like Clinical Trials, Cro, Clinical Development, Ctms, Pharmaceutical Industry, Gcp, Protocol, Drug Development, Regulatory Submissions, Therapeutic Areas, Clinical Research, Cross Functional Team Leadership.
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