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Job Details

Senior Clinical Data Manager – Boston, Home based US (East Coast)

Company: Clintec
Location: Boston, MA
Reference: US-SDM-140318-MC
Closing Date: 11 Jul 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

The Senior Clinical Data Manager permanent position based in Boston (Homebased role)

Requirements:

Senior Clinical Data Manager – Boston, Home based US (East Coast) 

 

Role Purpose

The Senior Clinical Data Manager is responsible for the day-to-day operational activities of clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements.  This activity is coordinated in conjunction with one or more vendors and, where appropriate, Clinical Operations staff. Mentoring and support of junior Clinical Data Management staff as expected.

 

Key Accountabilities:

  • Medidata Rave experiences essential
  • Oncology experience highly desirable 
  • Act as Senior Data Manager for assigned studies. 
  • Accountable for timely deliverables of all DM activities of their assigned projects
  • Projection and management of Data Management study timelines
  • Tracking of billable hours for the DM team against the budgeted hours
  • Flag resourcing needs to the Team Lead as and when required
  • Track and Monitor KPIs for their assigned studies.
  • Complete project trend analysis of all issues flagged in the issue tracker for their assigned studies and discuss with the team to achieve quality data
  • Ongoing internal oversight of study status and update the status tracker regularly and report to management periodically.
  • Responsible for timely completion and quality of the study start up documents like eCRF/CRF design, aCRF, Data Management Plan, Data Validation Plan, eCRF completion guidelines etc. as applicable.
  • Responsible for study set up of Clinical Data Management System (CDMS), and ensures completion of systems and tools to enable successful trial execution and reporting
  • Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy. This will include reviewing and resolving all discrepancies.
  • Ensure third party recon are delivered as per required quality and timelines for their assigned studies
  • Track and Monitor the discrepancy status for their assigned studies to ensure quality and timely deliverables.
  • Track and Monitor the SAE recon and Medical Coding status for their assigned studies.
  • Perform Medical Coding activity for assigned studies as applicable.
  • Perform close out activities for their assigned studies.
  • Accountable for timely deliverables of all DM activities of their assigned projects

   

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package. 

Apply for this job: Senior Clinical Data Manager – Boston, Home based US (East Coast)

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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