Oncology Account Manager

  • Jazz Pharmaceuticals
  • Indianapolis, IN, USA
  • Aug 15, 2019
Business Development Consultant Health Care Management Marketing Pharmaceutical Research Science

Job Description

The Senior Clinical Trials Manager (Sr. CTM) will be a member of the Jazz Pharmaceuticals Development Operations team. The Clinical Trials Manager responsibilities include (but are not limited to) the following: 

Essential Functions

  • Manage external vendors and contract research organizations
  • Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
  • Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
  • Assist with protocol development and study report completion
  • Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
  • Provide guidance, direction, and management to CRAs
  • Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
  • Coordinate study supplies
  • Negotiate contracts with vendors of clinical trial services
  • Review Informed Consent Forms, CRFs, and study related materials
  • Plan and participate in investigator meetings
  • Assist and support data query process
  • Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
  • Ensures trial master file is current and maintained

Required Knowledge, Skills, and Abilities

  • At least 5 years of experience in clinical trial management
  • Experience in Oncology is preferred
  • Proven Management of people in a matrixed environment
  • Management of global clinical trials
  • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
  • Demonstrated ability to work independently and in a team environment
  • Travel required. Must be willing to travel 15-25%, including international travel
  • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
  • Excellent oral and written communication skills and strong organizational abilities

Required/Preferred Education and Licenses

  • BA/BS, nursing degree, or advanced degree.  Degree in the life sciences preferred

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.