Beth Meyer Email & Phone Number

Phoenix, Az, Us

Phoenix, Az, Us

Dublin, Ie

Provide professional management and leadership of Program Managers, Project Managers and Clinical Trial Managers globally to ensure cross functional development teams achieve and exceed client expectations, with financial health outcome. Provide guidance from a cross functional development and management perspective to lead strategic assets to market. Assess health and risk through KPIs and KRIs while reporting status to global executive management and varying stakeholders. Provide key strategies to maintain corporate business goals, averaging over fifty million usd in book to bill business annually. Serve a SME for key growth development initiatives within the organization.

South Plainfield, New Jersey, Us

Durham, North Carolina, Us

•Serve as a company operations leader and liaison across assigned programs•Develop and maintain working relationships with client to ensure opportunity for additional business•Participate in new and repeat business proposal development, including operational strategy, budget preparation, and bid defense preparation/presentation•Facilitate the resolution of any issues, such as project staff performance, turnover on the project, invoice payments, change of scope negotiations, etc.•In collaboration with assigned project leaders, monitor project work flow and review resource requirements•Review project financials and profitability including revenue reports, change order, invoicing and payment status•Assist project lead with identifying, documenting and escalating issues impeding successful delivery of services to assigned client(s)•Monitor development, implementation and adherence to project plans, contracts and contract amendments for assigned clients•Participate in regular project reviews to ensure projects are proceeding within timeline, quality, budget, customer satisfaction and resource utilization expectations•Work closely with and provide mentoring to project teams to ensure they are communicating, interacting, collaborating, and cooperating•Work with leadership in all company functional areas on continuous development of business processes and process improvements to support cross-functional teams and ensure project/program work is uniform, complete and managed appropriately across all assigned projects •Provide overall leadership of the assigned cross-functional project teams to ensure the assigned program is delivered successfully, on-time, within budget and according to client expectations•Train, mentor, support and provide leadership to direct reports and to assigned project teams•Supervise, mentor provide feedback and career development opportunities for assigned direct reports•Coordinate, write and deliver performance management reviews

Plano, Texas, Us

- Senior project interface with Strategic Partners (Ex-US and Asia Pac)- Developed and managed integrated NDA submission plan- Oversee the development and maintenance of metrics to assess operational performance within varying cross-functional areas- Generation and maintenance of integrated development plan containing project description, resources, timelines, financial forecasts, and change summaries- Integrate and manage processes for progress monitoring, tracking and change management- Facilitation of program development, study level, and ad hoc strategy meetings- Project Manager for global study drug program (early to late stage development)- Facilitate the generation, review and finalization of protocols, SAPs, Annual Reports, DSURs, IB, CTAs, and CSRs- Key contributor: Integrated Development Meetings, Regulatory Strategy Meetings, BOD Presentations, Department and Study Budget Generation

Plano, Texas, Us

Plano, Texas, Us

Austin, Texas, Us

- Serve as senior project interface with clients, as well as project management responsibilities- Manage clinical trials throughout all stages of project development and execution- Perform management functions including budget preparation and strategic planning - Oversee the development and maintenance of metrics to assess operational performance- Oversee development of systems, training, and procedures for effective management of daily operations, effective management of personnel, and expansion of customer offerings- Perform business development responsibilities as required

Wilmington, Nc, Us

- Oversaw multiple projects through proactive risk assessment- Maintained client relationships- Managed personnel issues with project teams- Prepared and executed presentation of project specific and therapeutic training to clinical project teams- Tracked and managed budgetary issues for projects- Participated in Project Team and Executive Review Meetings to communicate progress of studies, quality issues, budgetary issues, and operational concerns- Interacted with assigned contact in PPD QA to ensure project compliance with ICH GCP and FDA CFR- Orchestrated internal and external project team meetings that were inclusive of representatives of PPD clinical, client representatives and personnel from external vendors- Ensured project team completion of PPD and client procedural - Prepared and presented of GCP/ICH Guidelines, Source Documentation Requirements and Drug Accountability Procedures at several Investigator meetings- Secured repeat business from clients through quality and delivery of services

- Mentored junior clinical team members on several protocols- Conducted, documented and trained others on all types of monitoring visits- Managed several investigational sites and several protocols at the same time - Assisted with identification and evaluation of potential investigators- Attended and presented at Investigator meetings- Participated in the development of CRF guidelines and monitoring tools- Performed Pre-Study, Initiation, Interim Monitoring and Close Out visits according to applicable Standard Operating Procedures and FDA guidelines

Kalamazoo, Mi, Us

- Served as Project Leader for global clinical studies in the Periodontal/Oral Max Facial program- Protocol development- Created Case Report Forms- Developed database verification plan- Performed Pre-Study, Initiation, Interim Monitoring and Close Out visits according to applicable Standard Operating Procedures and FDA guidelines

Canton, Massachusetts, Us

- Conducted Pre-Study, Initiation, and Interim and Close-Out Monitoring Visits- Served as the primary contact for clinical sites and Central IRB- Completed site visit reports, adverse event reports, site payment summaries and monthly progress reports- Assisted in the development protocols, informed consents, case report forms, material needs, budgets, contracts, corporate annual reports, and pre-market approval applications

Liberal Arts

Textiles / Marketing