Debra Mansfield Email & Phone Number

Malvern, Pennsylvania, United States

Retired

Princeton, Nj

Implemented company sponsored global clinical trials for post-approval regulatory commitments and publications for marketing support. Study oversight included design and execution of protocol and creation of study materials, monitoring plans, investigator recruitment and training materials, CRA and data management vendor oversight, and data analysis/review, clinical study reporting, and publication support.

Collegeville, Pa

Led global anti-infective clinical research lifecycle programs across Phase 3b/4 platforms for Zosyn/Tazocin (IV beta-lactam/beta lactamase inhibitor combination) and Tygacil (IV glycylcycline) as well as other anti-infective products that garnered over $1 billion in annual sales.

Collegeville, Pa

Supervised the planning, implementation, and management of multiple Phase 4 lifecycle clinical trials. Responsible for managing 2 Clinical Scientists and one contract employee.

Collegeville, Pa

Ensured the successful and timely completion of all aspects related to a large North American Phase 4 complicated intra-abdominal infection study consisting of 50+ investigator sites which resulted in a number of supportive scientific publications to grow the franchise.

Collegeville

MANAGER, CLINICAL RESEARCH - ANTI-INFECTIVES (1999-2000)SR. CLINICAL RESEARCH SPECIALIST (1997-1999)CLINICAL RESEARCH SPECIALIST (1995-1997)CLINICAL RESEARCH ASSOCIATE (1994-1995)CLINICAL RESEARCH ASSISTANT (1992-1994)CLINICAL DATA COORDINATOR (1991-1992 temp position) Nine years Clinical R&D experience in anti-infective research culminating in the successful approval and subsequent commercialization of two antibiotic products (Synercid, an IV streptogramin combination and Zagam®, an oral quinolone).