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. Review of draft informed consents. Review and approve IP release. Oversee regional Site Managers. Review and approve monitoring visit reports. Participate in global study team meetings. Lead and participate in Site Manager meetings.

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 meetings. TAs of Oncology and Endocrine.

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 queries and oversee resolution of queries. Review protocol deviation reports.

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 (AML); managing two CRAs. Responsible for the implementation and management of all aspects of clinical trial activities. Participate in vendor selection (CRO's, Labs, Drug Packaging, etc.). Oversight of CRO's and all outside vendors. Negotiate study level and site level budgets, and vendor budgets. Review contracts and Statements of Work in conjunction with Legal Department. Assist in protocol development, site selection, oversight of drug supply labeling, packaging and ordering. Oversee development and approval of all study plans (Project Plan, Monitoring Plan, Communication Plan, and Risk Management Plan). Perform co-monitoring visits of study sites. Ensure completeness of final study files. Act as liaison with the Safety group to monitor adverse events. Work in conjunction with Data Management to review draft CRFs (paper and electronic), edit checks, and assist with query resolution. Act as liaison with Quality Assurance for coordinating and assessing site compliance with GxP guidelines. Participate in site and Clinical file audit responses. Coordinated and updated the Module 5 eCTD tracker for an NDA submission. Assisted in preparations for an Advisory Committee meeting. Present at investigator meetings. Manage clinical trial team meetings.

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 packages for regional monitors. Site management of 24 sites for two ongoing xerostomia studies. Prepare documents for transfer to sponsor. Review regional monitor trip reports. Review regional monitor visit schedule. Order and ship supplies (including CRFs, study drug, and lab supplies) to sites. Collect regulatory documents from sites and update as required. Interact with Data Management to assist with query review and resolution.

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 Group, Accounting and Central File Group. Manage two ongoing trials, one Phase IIIb and one Phase IV. Oversee field monitors covering a total of 54 sites. Devise strategies to boost lagging enrollment for Phase IV study. Assist with study budget and contract preparation. Track study budgets. Study start-up activities for new Phase IIIb study. Recruit investigators. Review protocols, CRFs, and monitoring plans. Prepare documents for transfer to Central File Group.

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 status reports for sponsor, review and maintain study budgets, review all hours charged to these two studies, and review algorithms for new proposals by Business Development. Additionally, perform study monitoring visits, study file audits, pre-study site qualification visits, and close-out visits. Review of trip reports and expense reports. Recruit investigators. Prepare Earned Value Analyses for both studies. Review invoices prior to sending to sponsor. Prepare status reports for Pharmanet management. Develop protocols, CRFs, and monitoring conventions as required per contract. Organize and present materials at project kick-off and investigator meetings

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