Project Management Manager

SUMMARY

Knowledgeable Research and Project Leader with an extensive background in the pharmaceutical industry and CTOs. Effective team-oriented manager with excellent communication skills and supervising experience. Proficient in developing and achieving research agendas, project timelines, and milestones. Competent and efficient member of multidisciplinary, international, multi-site project teams. Clinical trial experience including the management of multiple projects to schedules. Broad background in regulatory oversight, project management, and compliance requirements. Demonstrated leadership, product management, team building and interpersonal skills.

PROFESSIONAL EXPERIENCES

ADP, Allentown, PA

Implementation Project Manager - 2023-Present

Key client owner and single point of contact responsible for the project management of the entire implementation and/or merger and acquisition, from the point of sale through the transition to on-going Client Services.

Project manages the work of several internal departments, clients, financial advisors and client's prior recordkeeper to ensure a successful implementation.

Perform welcome calls and explain the implementation process to the client, ensuring the client understands the actions they need to take in order to ensure successful implementation.

Assist client with prior recordkeeper notification and obtaining a liquidation date.

Provide the client with a blackout notice and explain the legal responsibilities for providing the notice to their plan participants in a timely manner.

CATALENT PHARMA SOLUTIONS, Kansas City, MO

Project Manager, Clinical Development and Supply - 2022-2023

Under own direction, coordinate projects from award stage to completion ensuring correct planning timelines are generated, monitored, and tracked for successful adherence and completion.

Lead the implementation of new clinical and/or commercial projects including source documentation

Attend and produce minutes and actions for client meetings, teleconferences, and client visits.

Utilize and drive Workfront for day-to-day project activities.

Manage inventory reporting and monitor and track client inventory in line with project requirements.

CHARLES RIVER LABORATORIES, Malvern, PA

Senior Manager, Project Management, Biopharmaceutical Services - 2007-2022

Managed national and international project teams by developing project plans, milestones, and major deliverables. Interacts with clients, investigators, sample processing, technical operations, and quality assurance to ensure timelines are met and deliverables are achieved. Provides periodic updates to clients.

Negotiates contracts, statement of works, and overall project scopes for approximately 30 US and global clients.

Tracked project deliverables and reported Key Performance Indicators (KPIs) to upper management.

Delivered presentations at Corporate Sales Meetings.

Manager, Client Services, Biopharmaceutical Services2004-2007

Managed inside sales, includ2001-2003ing pricing, bid and proposal generation, to ensure smooth and timely business process flow. Managed the database tracking system(s) to monitor and report proposal turnaround time, bid proposal volume, and bid effectiveness. Managed departmental resources for responsiveness to client needs.

Initiated project management approach to priority projects and preferred provide clients which resulted in increased efficiency, coordination of laboratory activities and achievement of timelines.

Increased effective communication between staff, scientists, and clients which ensured a smooth project flow.

Created weekly reports/updates to upper management enabling a constant flow of information.

AVENTIS PASTEUR, Swiftwater, PA

Platform Leader, Clinical Immunology, North American Analytical Sciences & Assay Development - 2001-2003

Managed laboratory in support of vaccine clinical trials. Interacted with clinical development/operations, clinical QA, regulatory affairs and data management to ensure completion of clinical trials according to the project timelines. Negotiated contracts, developed budgets and managed various projects involving external vendors and consultants. Represented the platform on project teams to coordinate clinical testing, data management and protocol/CSR review. Created, tracked and distributed periodic project status reports to the project teams, senior management and customers.

Increased the size of the Clinical Immunology Platform from less than 20 to approximately 50 scientists and technicians enabling fast response time on testing demands and priority projects.

Participated in data audits and installed measures to ensure the data integrity and compliance with SOPs/ protocols. Results were increased efficiency and expedited data analysis.

Served as integral member of global project teams including the centralization of Clinical Immunology between the French and Canadian laboratories, successfully transferring assays from these sites.

Research Scientist, Clinical Immunology, Swiftwater, PA - 1997-2001

Transferred assays into new laboratory on site.

Managed contractors responsible for the GMP validation according to regulatory guidelines.

BALTIMORE VA HOSPITAL, Baltimore, MD

Managing Director, Clinical Research Unit - 1996-1997

Coordinated and supervised pharmacokinetic drug trials; oversaw budgets, consent forms/IRB approval and source documentation and recruiting, and scheduling.

Developed/managed study budgets, timelines, source documentation and coordinated protocol execution.

Supervised staff, obtained IRB approval, and hired personnel to execute protocols.

UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE, Baltimore, MD

Assistant Professor, Dept. of Medical and Research Technology - 1992-1997

Served as Discipline leader for the Clinical Chemistry group. Presented lectures on Biochemistry, Clinical Chemistry and Statistics. Served as Principal Investigator for clinical trials involving glucose monitors.

Conducted basic research involving superoxide production in human neutrophils.

HOWARD COMMUNITY COLLEGE, Columbia, MD

Adjunct Professor of Chemistry, Science Dept. - 1990-1997

Lectured on Organic Chemistry.

USDA/ARS/BHNRC, LIPID NUTRITION LABORATORY, Beltsville, MD

Postdoctoral/Research Associate - 1989-1992

Conducted basic research involving ionized calcium fluxes in rat platelets.

Involved in a clinical trial evaluating the effect of trans fatty acids on lipid profiles in human volunteers.

EDUCATION

Ph.D./M.S, Clinical Chemistry, Cleveland St. Univ., Cleveland, Ohio 1989/1985

B.S., Chemistry, King's College, Wilkes-Barre, PA 1983

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