Elizabeth Carter Email & Phone Number

Waltham, Ma

As VP of Client Delivery I am accountable for all aspects of operational account leadership for our project teams overseeing clinical trials across many therapeutic areas and phases. This entails account management, resource management, budget development and management (department and program), operational delivery in accordance with all regulations, risk management, client delivery and support of strategic initiatives.

Waltham, Ma

As VP of Functional Solutions my accountabilities include refinement of strategic plan to build our requisite business model, tactical implementation of plan including refinement across key areas of operational delivery, marketing plan, training, and financial management.

Waltha, Ma

Overall accountability for client relationship management and to verify appropriate delivery across all departments and necessary infrastructure is in place, includes interfacing with the sourcing group and supporting strategic development to expand account services.Key focus is to provide strategic input into portfolio expansion into Early phase, Late Phase, Regulatory Strategy and Commercialization based on pipeline needs of strategic account. Responsibilities, include direct oversight for all activities related to portfolio level P&L, program management (strategy, timelines, budget), regulatory strategy and quality oversight activities for Phase I to IV studies for a strategic account. Oversee multi-therapeutic and multi-functional program strategy, recruitment, planning, program management, and supervision of project management staff (Project Managers, Project Directors, Financial Analysts), to ensure satisfaction, programs achieve milestones, business objectives and meet contractual obligations with strategic partner. Accountable for planning and executing clinical-regulatory, pharmacovigilance, data management, biostatistics and programming, medical writing, regulatory submission, and quality audit program timelines and quality deliverables based on contractual obligation and sponsor specifications. This includes staff training, development, compliance and performance for all Project Director, Project Management, and other operational staff. Coordinate cross-SBU departments to verify delivery for programs and account level needs are met.

Parexel International Waltham, Ma

Direct management of up to 10 Project managers and Project Directors. Oversee recruitment, planning, program management, departmental budgets, risk management and supervise project management staff to ensure programs achieve milestones, business objectives and meet contractual obligations with Sponsor companies. Provide expertise to help design Phase I to III development plans, protocols and regulatory strategy. Plan and execute clinical program timelines and quality deliverables based on contractual obligation and sponsor specifications, responsible for staff training, development, compliance and performance.

Waltham, Ma

Primary function is to provide high level project oversight and organizational leadership. General responsibilities include: Supervision and management of senior managers and their respective staff; ensuring managers and staff are trained; mentoring and career development for managers; oversight and management of the execution and profitability of the data management activities on projects; adherence to GCP and PAREXEL standard guidelines and processes; continuous productivity improvement. Additionally responsibilities are to regularly assist in business development opportunities and assume responsibility at an account level, including marketing and new business meetings.

Waltham, Ma

Responsibilities include; assignment of resources across multiple projects, evaluate time spent for data management projects, liaise with project management to ensure timelines and budgets are achieved with high quality, provide feedback to personnel on performance, assessment of training needs for employees, participate in project team meetings as necessary, and facilitate CDM’s work by eliminating barriers and providing support. Additional tasks involved strategy development for DM activities involved in Phase IV studies, EDC Process strategies, coordinate roll-out of financial/metric tool in NA with champion from UK, and working on cross-functional improvement initiatives. Other responsibilities included establishment of data management checks, review of case report forms, integration of data queries, review and resolution of data discrepancy listings, quality control, and serving as primary on two studies. Therapeutic areas include endocrine, infectious disease and oncology.

Randolph, Ma

Responsibilities include coordination of technology transfer of product moving from lead to clinical phase with multiple international sites; including project coordination efforts between sites, providing reports and protocols for processes, train sites in techniques, and reviewing and adjusting timelines to ensure realistic, but progressive timelines. Other responsibilities included; development of processes for the purification of proteins under GLP guidelines for multiple proteins to supply worldwide groups for pre-clinical studies, develop research proposals for Reproductive Endocrinology projects, and present results at project planning meetings. Therapeutic areas included multiple sclerosis and infertility.

Hopkinton, Ma

Responsibilities include development of processes for commercial scale production of protein, coordinate technology transfer and train manufacturing personnel in new processes, author technical reports, write and review SOPs necessary for GMP campaign, and present data at project meetings. Therapeutic areas include cancer and autoimmune diseases.

Cambridge, Ma

Responsibilities included development and implementation of processes for clinical grade protein under GMP conditions, coordination of large scale experimentation to create a more efficient and cost effective clinical process, and maintenance of training records. Therapeutic areas included cancer and inflammation.

W. Lebanon, Nh

Responsibilities included development of processes for the pre-clinical and clinical production of monoclonal antibodies, coordination and scheduling of clinical production, inventory control, and assistance in preparation and reviewing documentation for submission of INDs. Therapeutic area includes cancer and Infectious Disease.