Business Development Director, Early Clinical Services @ Covance
Senior Project Manager, CPM, Study Start-up @ Covance
Global Clinical Project Manager (for Wyeth/Pfizer) @ inVentiv Health
Associate's Degree, Pre-Nursing Studies @
Gulf Coast State College
Scientific professional with a strong clinical operations background and business development experience in the biotech and pharmaceutical industries. Strong interpersonal skills and highly analytical, yet versatile, with strong work ethic and desire to exceed customer expectations. Proven ability to lead global teams, develop solid working relationships with high-level medical and scientific professionals and produce positive outputs in
Scientific professional with a strong clinical operations background and business development experience in the biotech and pharmaceutical industries. Strong interpersonal skills and highly analytical, yet versatile, with strong work ethic and desire to exceed customer expectations. Proven ability to lead global teams, develop solid working relationships with high-level medical and scientific professionals and produce positive outputs in a dynamic work environment. Focused interest in partnerships and providing solutions to emerging biotechs and mid-size pharmaceutical companies.
Business Development Director, Early Clinical Services @ Business development for Early Clinical Services supporting biotech and pharmaceutical clients in the Southeast. Well-versed in the full spectrum of services to support clinical pharmacology, first-in-human/patient, early oncology, and PoC studies. Significant years’ of project management experience in the ‘client seat’ with a full understanding of the drug development process and how important it is to partner with the right CRO. From January 2015 to Present (10 months) Orlando, Florida AreaSenior Project Manager, CPM, Study Start-up @ Certified Project Manager
Led global project teams during study start-up phase and ensured effectiveness across the functional lines of the team, both internal and external, with multiple clients and therapeutic areas. Proactively engaged the team in risk management and quality assurance activities to deliver project milestones according to both Covance and client requirements. Monitor project schedule and scope to ensure both stay on track; plan mitigations as necessary. Manage the study budget and develop project plans across assigned projects. Enhance operational excellence and overall client satisfaction by establishing and maintaining client relationships. Prepare and attend bid defenses for new work; prepare and lead start-up strategies at kick-off meetings and other face-to-face meetings with clients. From November 2012 to January 2015 (2 years 3 months) Princeton, NJGlobal Clinical Project Manager (for Wyeth/Pfizer) @ Contracted to Wyeth, then Pfizer.
I led the global operational delivery at the study level through facilitation and effective decision making. I created and drove study timelines across all functional lines, assuring quality and achievement of key milestones; tracked against study plan from study start-up to final CSR. I also provided critical operational input to study design by contributing to protocol development. Influenced strategy and ensured operational alignment; proposed alternative operational solutions to optimize use of time, cost and resources. Established and managed study budget and forecasts. From October 2006 to November 2012 (6 years 2 months) Collegeville, PA, then home-based in 2008Clinical Scientist @ Participated in the selection and management of full-service CROs and other 3rd party vendors to conduct the operations of clinical trials. Managed overall study timelines to achieve efficient and effective clinical operations. Generated protocol amendments and composed informed consent documents (including assent for pediatric trials). Developed and negotiated budgets and contracts with CROs, vendors and investigative sites. From August 2004 to October 2006 (2 years 3 months) Wayne, PaClinical Research Associate @ Trained in-house and field CRAs, provided daily mentoring and report review for CRAs in the field. Performed site qualification visits, site initiation visits, routine monitoring and close-out visits; generated trip reports and other site communications. Reviewed and approved subject informed consents prior to and post IRB approval. Reviewed and tracked regulatory documents (TMF) at the site and in-house. From May 2001 to August 2004 (3 years 4 months) Malvern, PAClinical Study Coordinator @ Recruit patients to participate in Phase 2-4 clinical trials. Responsible for informed consent procedures and assisted in study procedures for subjects meeting study criteria. Maintained accurate source documentation, CRF completion, query resolution and drug accountability. From June 2000 to May 2001 (1 year) Reading, Pennsylvania AreaMedical Specialist @ Managed patients in an emergency situation from triage at the scene to discharge or admission at 100-bed hospital. Trained and certified as an Emergency Medical Technician; ACLS certified. From March 1994 to March 1998 (4 years 1 month) Tyndall Air Force Base, Panama City, FL
Bachelor of Science (B.S.), Nutrition Sciences @ Penn State University From 1998 to 2000 Associate's Degree, Pre-Nursing Studies @ Gulf Coast State College From 1996 to 1998 Rebecca Lupo is skilled in: Sales, Project Management, Clinical Research, Clinical Trials, Clinical Development, CRO, Pharmaceutical Industry, Leadership, Contract Management, Inflammation, Neuroscience, Hepatology, Cardiovascular Disease, Research, Regulatory Requirements, Microsoft Office, Training, Protocol, Oncology, Drug Development, Biotechnology, GCP
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