Radius Health, Inc.

Clinical Trial Manager

US-MA-Waltham
1 month ago
Job ID
2017-1620
# of Openings
1
Category
Clinical Development

Overview

The Clinical Trial Manager manages and oversees clinical operation activities across a single clinical program or group of related studies, and ensures all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

Responsibilities

  • Contributes to Global clinical / regulatory submissions (FDA, EMA, Canadian and other countries), by helping with in house and site inspection readiness planning/training,
  • Manages clinical study/studies according to global regulatory requirements
  • Leads cross functional study execution team to ensure goals and timelines are met
  • Manages and oversees CRO/Vendors to ensure compliance with processes and regulatory guidelines
  • Manages MS Project timeline
  • Supports the tracking of trial budget(s) working closely with the appropriate partners. 
  • Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
  • Anticipates potential study issues and prepare contingency plans with minimal oversight
  • Facilitates Clinical Agreements through Clinical and Legal Review.
  • Reviews all study documents for accuracy and quality content. Draft sample preparation instructions, in accordance to Radius standard operating procedures (SOPs) and good clinical practice guidelines (GCPs).
  • Performs on site co-monitoring, training or motivational site visits, as needed
  • Drives traceability procedures for investigational products and coordinates clinical supply planning with cross functional team members
  • Develops study specific documents such as pharmacy and operational manuals.
  • Reviews and approves, as needed, study documents such as monitoring reports, essential regulatory packages, ICFs, etc.
  • Trains CRO team members and site staff, as needed
  • Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management.
  • Provides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report.
  • Some travel will be required (10-20% depending on project needs)

Qualifications

  • BA/BS in a scientific field (preferred) of study with 5+ years of relevant experience working in Clinical Operations in the Pharmaceutical/ biotech industry and/or a CRO. CRA experience preferred.
  • Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) and all aspects of trial and vendor management.

  • Strong verbal and written communication skills

  • Ability to deal with competing priorities, detail oriented and creative problem solving ability is essential
  • Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required; basic statistical knowledge a plus.
  • Ability to work independently and also in a collaborative team environment
  • Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems)

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed