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Sr. Manager/CTM, Assoc Director/Director, Clinical Ops (Rare Disease)

Cambridge, MA 02139

Posted: 11/22/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2437

Job Description

The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role, external vendors and CROs.The position reports to the Clinical Operations Leader in the assigned Therapeutic Area.This role may work collaboratively on one trial or across several trials to support clinical operations activities.

Role Overview:
  • Day-to-day management of assigned clinical trial to ensure deliverables are met in all phases of trial
  • Communication to internal team members on deliverables and ensuring timelines are met
  • Manage trial feasibility process
  • Work closely with Rare Disease or Infectious Disease Clinical Operations Strategy Leader to implement Operations plan for Clinical Study Teams. 
  • Drafting site materials including training, manuals and support documentation
  • Monitoring of clinical data to ensure timely entry and readiness for data review meetings
  • Periodic review of clinical data
  • Review of clinical monitoring reports to ensure timely completion and identification of issues
  • Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
  • Maintain trial metrics
  • Ensure trial is conducted in accordance to client and ICH/GCP standards including multiple regions in global trials
  • Support the CRO in testing clinical trial systems/databases (i.e. UAT)
  • Develop and maintain strong, collaborative relationships with key stakeholders

  • At least 5 five years of trial coordination experience in a clinical research environment, some should be in industry
  • Advanced degree preferred or Bachelor’ s in a science-based subject
  • Relevant therapeutic experience in global setting
  • Solid understanding of drug development
  • Good project management skills
  • Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  • Excellent verbal and written communication skills
  • Good organizational skills and attention to detail

Meet Your Recruiter

Kelley Cole
Clinical Recruiter

Kelley brings 5 years of experience in full life-cycle recruitment and talent acquisition management, along with a strong client services background, to her role as Clinical Recruiter for The Steely Group. A desire to make a difference and add positivity to this world are two factors that influenced Kelley’s decision to become a recruiter. “Connecting a candidate with a better opportunity that could have a huge impact on them and their family is very fulfilling,” she says.

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