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AD of Clinical Operations

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Cambridge, MA
$110,000 - $140,000
Job Type
Direct Hire
Aug 01, 2016
Job ID
Job Description
Reporting to the Director, Clinical Operations, the successful candidate will manage clinical project activities ensuring the timely completion of deliverables through development and management of the project timeline and budget. Must be comfortable managing a clinical project through the use of vendors, and be able to manage interactions with and between monitoring, data management, biostatistics, medical writing, safety, regulatory affairs and QA. Externally manage CROs, field clinical monitors, and investigator site staff.
Required Skills
Responsible and accountable for one or more concurrent clinical studies Leverages resources, expertise and knowledge across projects Develops and manages trial budget & MS Project timeline Trains team members, including vendors, as needed Participates in contracts and budgets negotiations with clinical sites and vendors Participates in protocol development Develops critical study documents including informed consent forms, study conduct documents such as study manuals, study tools etc. Prepares investigational site lists, participates in reviewing and approving investigational sites based on complete site assessment Oversees preparation of Study Operations Manual(s) Participates in the coordination of investigator meetings and all other study management meetings Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed Participates in the dissemination of clinical information to the clinical team members Reviews and approves corrective action plans at individual site and across study, may participate in internal/external study related audits Must be able to monitor as needed
Required Experience
BS Degree in science or a health related field is required
Minimum 3-5 years relevant industrial Clinical Project Management and 7 -10 years of Clinical Development experience
Must be able to travel up to 20%, domestically and internationally
Good verbal and written communication skills
Excellent interpersonal and organizational skills
Detail oriented and good problem solving ability
Ability to work on teams and with multiple projects, and works well under general direction
Working knowledge of medical terminology
Excellent computer skills
Excellent knowledge of GCP, ICH and FDA regulations
Ability to provide appropriate leadership to clinical sites
Independently motivated