Senior Manager, Clinical Trials
Savient Pharmaceuticals, Inc. - Bridgewater, NJ

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Job Description Responsible for the design, planning, implementation and daily management, and reporting of clinical trials, as primary interface of Savient with a CRO partner.

Essential Duties and Responsibilities

Manages the interface with CRO, Central Labs and other specified vendors for clinical trials including:
  • Develops RFPs for assigned projects and manages bid solicitations and evaluations
  • Participates in the design of clinical trials with in-house team and CRO
  • Participates in writing/review of protocols, design of CRFs, project plans, and other documents pertinent to study design
  • Plans and tracks clinical trial milestones
  • Participates in the selection of study sites and the negotiation of budgets/contracts
  • Plans investigator meetings; may present as needed
  • Develops monitoring strategy and provides oversight to its implementation
  • Coordinates the data review and query resolution aspects of the study, through the CRO
  • Prepares monthly reports regarding study progress, budget issues, etc.; participates in the preparation of the final study report
  • Oversees tracking of study grants; oversees the tracking of clinical supply packaging and shipment to investigate sites through the CRO
  • Interacts with Legal, Regulatory, Logistics, Quality and other departments as needed for oversight or input into project critical issues (e.g., contracts, regulatory submissions, drug supply).
  • Maintains a high level of professional expertise by enhancing working knowledge of Federal regulations and keeping abreast of current developments and advancements in relevant therapeutic areas

Clients
  • Project Lead
  • CRO Project Manager
  • External Service Providers (e.g., central labs, patient recruitment services, etc.)
  • Project Physician
  • Biostatistician
  • Quality Assurance Lead
  • Manufacturing Lead
  • Project Administrative Assistant
  • Senior Director, Clinical Operations

Qualifications Education Requirements
  • B.A./B.S., preferably in Health Care discipline, from a four-year college or university
  • An advanced degree (M.S. or PharmD, nursing degree) desirable.
Experience Requirements
  • Seven or more years related pharmaceutical industry experience in clinical
research/operations including 4 years experience in managing clinical trials
  • Demonstrated organizational and management skills and able to create/track a budget
  • Experience with management of clinical trials in different development phases helpful
  • Experience as clinical trial manager or clinical trial monitor at a CRO helpful

Other Skills and Abilities Required
  • Excellent written and oral communication skills
  • Ability to read, analyze, and interpret scientific and technical journals and financial reports commensurate with role as clinical trial manager
  • Ability to respond to inquiries/complaints and develop/maintain good rapport with colleagues, investigators, vendors, and others
  • Ability to write protocols and status reports that conform to prescribed style and format, and are compliant with regulatory requirements
  • Understanding of basic statistical concepts as related to study design
  • Ability to manage the tracking of study grants, planning and tracking study budgets
  • Strong analytical skills
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to interpret an extensive variety of technical information relating to clinical trials
  • Strong working knowledge of MS Office, especially Word, Excel, Project, and PowerPoint

Additional Information Savient believes that benefits are an essential component of an employee's compensation package. Our benefits package is designed to deliver competitive, valuable options to our employees. Savients benefits package includes:
  • Medical
  • Vision
  • Life and AD&D Insurance
  • Long Term Care Plan
  • Flexible Spending Account
  • Employee Stock Purchase Plan
  • Competitive Vacation Policy
  • Tuition Reimbursement
  • Dental
  • Employee Assistance Program (EAP)
  • Short- and long-term Disability Insurance
  • Travel Accident Insurance
  • 401K Plan
  • Voluntary Life Insurance
  • Employee Referral Program

Savient Pharmaceuticals, Inc. - 21 months ago - save job
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