Clinical Trial Manager with VIVUS, Inc.

VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. Analysts speculate that the potential market for obesity ranges from $5 billion to $10 billion annually, the potential market for an effective diabetes therapy that causes weight loss is in excess of $2 billion, and the indications targeted by VIVUS' sexual health products each represent a projected market greater than $1 billion annually.

 

Summary: 

 

As a member of the clinical operations team, the Clinical Trial Manager will work with fellow team members in designing, planning, implementing, & executing clinical trials in accordance with company SOPs, FDA, & ICH guidelines and regulations.

 

Responsibilities:

 Independently manages multiple concurrently ongoing clinical studies/programs.Coordinates and manages vendors and contract personnel.Coordinates and oversees activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.  Drafts protocols Coordinates the in-house start-up and close-out of clinical studies.  Plans, oversees, and performs Pre-Study Visits, Study Initiation Visits, Interim Monitoring Visits, Study Close-out Visits.  Ensures regulatory and legal requirements are met prior to site initiation (IRB approvals, contracts, 1572s, CVs).  Drafts and organizes clinical materials including, but not limited to informed consents, source documents, patient instruction guides, project tools, site visit reports and case report forms and study metrics.Drafts clinical budgets and contracts, and approves payment summaries for investigators and vendors.Drafts and negotiates clinical budgets and coordinates contract negotiations. Coordinate vendor and investigator payments. Coordinates and participates in project team meetings.Evaluates clinical data and assists in planning of data analysis.  Organizes and drafts presentations for professional meetings hosted by VIVUS. 

Requirements:

 4 to 8 years clinical research experience required. Prior drug development experience and clinical site monitoring experience required.MS/BA/BS, health related field, or equivalent work experience. Excellent written and interpersonal skills required. Must be able to communicate effectively with clinical, cross-functional, and external teams. Knowledge of GCP regulations required.Knowledge of medical terminology, drug therapy techniques, clinical patient management required, and clinical research methodologies.Able to travel up to 30% preferred.Expert use of Word, Excel, Power Point Outlook, and Adobe Acrobat needed.