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Trial Master File Manager
Ref No.: 18-01772
Location: Waltham, Massachusetts
Position Type:Full Time/Contract
Shift:First
Job Category:Research & Dev
Benefits:Medical Insurance
Clinicial Quality Specialist
Overall a clinical R&D Quality Assurance (R&D QA) support role for routine activities of R&D QA clinical study support and Good Clinical Practice (GCP) Inspection Readiness and Auditing Activities.  The purpose of this role is to provide support to the Risk Assessment Lead and ongoing R&D Quality Assurance Activities coordinating documentation review, report reviews, and general documentation activities.

Job Location:  Waltam, MA
**Temp to Perm position
 
Overview:
On-Board Services, a Family-Owned U.S. Based Professional Staffing and Search Firm, is assisting a global biotechnology company.
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The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, New Jersey along with Regional Offices in New Castle, Delaware, and Raleigh, North Carolina. 
 
 
Qualifications:
  • Minimum  5 years of relevant experience in research or clinical Pharmaceutical or Device Industry with significant role in documentation coordination
• Strong knowledge GCP in clinical research activities (US, EU and ICH E6 (R2) GCP) 
• Experience with Rare diseases or with vulnerable population in clinical studies of drugs and devices
• Experience revising SOPs and complex study documents
• Experience Managing project activities, documenting meeting decisions and actions, and facilitating completion of actions 
• Experience in clinical operations or Clinical Quality (clinical research and/or hospital staff) preferred 
• Experience in Inspection Readiness or Audit oversight preferred
• Works well independently and in groups
• Takes direction and completes tasks with little supervision
• Demonstrated knowledge of risk management tools 
• Excellent organizational skills and strong attention to details 
• Works precisely as per procedures, rules and regulations 

Responsibilities:
  • Facilitation and support of Clinical Program activities related Inspection Readiness
  • Support CAPA, Audit Planning and infrastructure development activities and harmonization
  • Coordinate meetings, documentation reviews and facilitate action items related to planning activities and infrastructure development for R&D QA processes through the company and Assist in harmonization activities
  • Support clinical audit activities for internal and external audits (i.e. qualification and for cause audits) and clinical trials’ teams to ensure total compliance to applicable rules & regulations (study protocols, internal regulations, national & industrial regulations, and so forth)
Applying is EASY!  
To Apply for consideration
 please apply through this job board or send your resume to Regina Jarrell at Regina.Jarrell@onboardusa.com  and reference job #18-01772 in the Subject Line.  If you meet the requirements above then I will likely contact you to assist you in becoming a candidate.
 
Disclaimers 

You cannot be begin a job with our client without successfully passing their standard pre-employment drug screen and background checks


On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.