Donna Walters Email & Phone Number

New York, Ny, Us

• 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.

Lawrenceville, New Jersey, United States

Princeton, Nj

Department 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

Bridgewater, Nj

Build 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

. 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.

Directed 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.

Directed 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.

Overall 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.

Overall 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.

Overall 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.