Job Title: Project Manager, Clinical Operations
Date Posted: 12-15-2006
Job Location: Massachusetts-Boston
Job Type: Full Time
Education Level: Bachelors Degree
Work Experience: 5+ to 7 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: Idenix Pharmaceuticals
Company Website: www.idenix.com/
Contact Information: Idenix Pharmaceutica   Idenix Pharmaceutica (hr@idenix.com)
Job Description:
Project Manager  Clinical Operations
Description:
Reporting to the Director, Clinical Operations and working closely with Senior Management in
Clinical Research, the Project Manager, Clinical Operations will be responsible for assisting
the Director, Clinical Operations with the planning and all aspects of conduct of clinical
research studies. The Manager, Clinical Operations will contribute to clinical study design,
monitoring, quality assurance, data management, and reporting activities. The Manager,
Clinical Operations will act as an effective, informed project manager for a study or group of
studies, keeping the projects on track in terms of milestones and budget. The Manager, Clinical
Operations will provide technical services for the collection, review, maintenance, and
tracking of regulatory documents for clinical study centers; identify and follow current FDA
regulations and ICH and GCP guidelines for clinical studies; provide support to contract
Clinical Research Associates as well as mentoring and training less experienced Clinical
Operations team members; audit central files; and collect, track, and summarize patient
information. Infrequent travel may be required. 
Primary responsibilities of the Project Manager, Clinical Operations include: 
 Application of advanced skills in managing clinical studies and associated vendors without
supervision 
 Preparation of study materials and documents including Clinical Operations sections of
protocol, informed consent templates, case report forms etc. 
 Drafting Request for Proposals (RFPs) for outsourced studies 
 Critically reviews data listings and tables, as needed for clinical study reports and other
study documents 
 Performs financial tasks including: 
o Drafts and tracks study budget and addresses variances 
o Demonstrates budget awareness throughout study life cycle 
o Manages and tracks financial payments 
 Prepares and distributes regular clinical project updates 
 Works with project team members to establish goals and objectives 
 Plans and creates presentations of clinical study information 
 Writes and maintains Clinical SOPs, as required 
 Prepares training materials for new employees 
 Performs literature searches 
Requirements: 
 Minimally a Bachelor's degree in a health-related discipline, or an R.N. nursing degree 
 At least three years experience as a clinical project manager in CRO or Pharmaceutical
Company; Monitoring experience, in addition to the above, very desirable 
 Knowledge and understanding of current regulatory issues related to Phase I-IV clinical
research 
 Excellent knowledge of project management tools and practices 
 Excellent communication and organizational skills 
 Comprehensive knowledge of Microsoft Word, Excel, and PowerPoint 
Preferred candidates will have experience in clinical trials of infectious diseases
therapeutics, ideally including antivirals. 
Idenix offers an excellent benefits package including competitive salary, equity compensation,
major medical insurance, dental insurance, 401(k) plan participation, and group life and
disability insurance. 
To be considered for this position, please send your resume by email to hr@idenix.com , or by
mail to:
Human Resources
Idenix Pharmaceuticals
60 Hampshire Street
Cambridge, MA 02139
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