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Sr Clinical Operations Consultant
Ref No.: 18-00761
Location: Watertown, Massachusetts
Start Date: 01/22/2018
 Senior Clinical Operations Consultant
 Position Description: The Senior Clinical Consultant will manage as aspects of clinical development/studies, data collection and verification, monitoring of clinical sites (including ability/experience to monitor studies themselves and ability to supervise a contract clinical trial  monitors), adherence to protocols, development of budgets and work orders, and all aspects of clinical study conduct.
  • Ensures that clinical study protocols are properly constructed, written, and executed in accordance with ICH/GCP standards.
  • Participates in the design of clinical studies, CRO and vendor qualification and selection, outsourcing strategy, etc.
  • Ensures that the clinical study budgets are properly developed, resourced, managed, and executed within budget and according to relevant guidelines for quality and relevant timelines.
  • Prepares protocol, CRF, amendments, informed consents, patient information leaflets (etc.), and all documentation associated with clinical trials.
  • Maintains and manages internal clinical trial documents in accordance with relevant SOPs and GCP guidelines, potentially participates in any GCP audit activities,
  • Assists in preparing necessary Regulatory documents (eg. Protocol amendments, annual updates, IB updates, CSRs, etc.)
  • Lead a multi-disciplinary clinical studies management team. Supervise all clinical contract employees (e.g. local contract CRAs) and may serve as the sponsor's on-site clinical monitor
  • Manages all day-to-day aspects of clinical operations including management of clinical trial vendors, drug supply, review of study deviations/protocol adherence, etc.
  • Participates in Investigator Meetings
  • Prepares and distributes clinical trial updates/summaries. May present to senior management to update clinical trial activities.