David Bini Email & Phone Number

Princeton, NJ

Supervise Clinical Trial Managers and facilitate their allocation across clinical trials supporting Global Clinical Operations Leaders in quality and efficient execution of global clinical trials, and managing performance and career development.

Princeton, NJ

On Assignment At Sandoz, Inc.

Assignment at Johnson & Johnson PRD, Global Clinical Operations. One-year renewable contract (two-year cap).

Raritan, NJ

TA of Oncology; Pain and Infectious Diseases. LTM for Phase 2 Prostate cancer study and Phase 2 Multiple Myeloma study. Similar duties as noted below. LTM for Phase 3 pediatric antibiotic study. Perform site feasibility. Oversee contract and grant process, regulatory document collection, site blinding plan finalization. Oversee updates to CTMS database..

Flemington, NJ

Project Manager for Phase 2 and 3 studies. Providing training for study personnel. Oversight of regional CRAs, review of monitoring reports, review of communication logs. Oversight of company CTMS. Oversight of EDC, IVRS, ECG and central lab vendors. Oversee set-up of Trial Master File. Lead/participate in team meetings, vendor meetings and sponsor.

I am currently working at Novartis, as an Expert Clinical Manager/Clinical Trial Lead.

Therapeutic area is Oncology (AML and solid tumor). Responsibilities include review of data listings, review of clinical study reports, review and writing study synopses, and writing and reviewing patient narratives. Review of draft protocols and case report forms. Review of Validation and Planning documents in conjunction with Data Management. Review of.

Manager of large Phase 3 and open-label trials in Parkinson's Disease, and Phase 1 oncology (AML) TRIALS.

Therapeutic areas were CNS (Parkinson's Disease), Oncology (AML).CTM for a Phase 3, 26-site Parkinson's Disease study. Assisted with the oversight of a second 74-site Phase 3 Parkinson's study. Assisted with the oversight of monitoring and close-out of the 90 North American sites in a 150 site global open-label study. CTM for a Phase 1/2 Oncology study.

Contract CRA with positions at Forest Laboratories (2001-2002) and Beardsworth Consulting Group (2002-2004)Company name has changed to Medical Staffing Network.

In-house CRA/Project Manager Therapeutic areas were Endocrine (Diabetes), Oncology-related (Xerostomia). Responsibilities included working as in-house CRA for two xerostomia studies, and a diabetes study. Primary duties were site management, enrollment tracking, review trip reports, oversee close-out of 86 sites for diabetes study, prepare close-out.

Therapeutic areas was Respiratory (Asthma).Responsibilities include working as Clinical Trial Manager for three asthma studies, tracking enrollment and patient status, processing site payments, reviewing regional monitor trip reports, and updating study status report which is sent to upper management. Regular interaction with Data Management, Contracts.

Therapeutic areas were Endocrine (Diabetes), Rheumatology (Juvenile Rheumatoid Arthritis (JRA))Responsibilities include working as Project Manager for a nine center Phase III JRA trial, overseeing two CRAs and a JRA Phase IV Registry study, with up to 27 centers, and being the primary contact for sponsor. Additional responsibilities were to prepare monthly.

Therapeutic areas included HIV Wasting (anabolic steroid for muscle mass replacement), Endocrinology (testosterone replacement therapy) and Neonatology (lung surfactant for premature babies).

Additional positions held: Clinical Research Assistant and Assistant Toxicoligist

Therapeutic area was Pulmonary (Asthma and Rhinitis) Phase 2 and 3.

Preclinical testing of various developmental and marketed products.

B.S, Animal Husbandry

A.A, Agriculture