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Trial Master File Manager
Ref No.: 18-04435
Location: Waltham, Massachusetts
Start Date / End Date: 04/09/2018 to 12/28/2018
Job Title: Clinical Quality Specialist/Coordinator​
Duration: 9 months
Location: Waltham, MA

Job Description:

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.
Responsibilities may include:
•    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)

Qualifications & Experience:
•    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

Skills & Competencies:
•    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 
•    Great “Can-do” Attitude

Shiva Prasad | Senior Recruiter
Sunrise Systems Inc.
Desk: (732) 272 0346
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