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Clinical Trial Manager, Clinical Operations, COVID Programs

Company: Integrated Resources
Location: Somerville
Posted on: June 18, 2022

Job Description:

Job Description
Job Description
The Role:
The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) 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 Director, Clinical Operations and is accountable to the Clinical Operations Lead for assigned studies.This role maywork collaborativelyon one trial or across several trials to support clinical operations activities.
Heres What Youll Do:
Day to day management of assigned clinical trial(s) 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 study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studies
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 with Client and ICH/GCP standards including multiple regions in global trials
Support testing clinical trial systems/databases (i.e. UAT)
May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacity
Develop and maintain strong, collaborative relationships with key stakeholders within Client
Heres What Youll Bring to the Table:
At least 5 five years of trial coordination experience in a clinical research and industry environment
Advanced degree preferred or Bachelors in a science-based subject
Relevant 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 detailJob SnapshotEmployee Type:Full-TimeLocation:Cambridge, MAJob Type:Health CareExperience:Not SpecifiedDate Posted:6/3/2022

Keywords: Integrated Resources, Somerville , Clinical Trial Manager, Clinical Operations, COVID Programs, Executive , Somerville, Massachusetts

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