Clinical Trial Manager, Clinical Operations, COVID

Clinical Trial Manager, Clinical Operations, COVID
  • $70 - $90 per Hour
    HOUR
  • Temporary
  • CAMBRIDGE MA, US CAMBRIDGE MIDDLESEX US 02139
Job Ref: JO000125289
Sector: Science
Sub-sector: Food & FMCG
Date Added: 10 November 2021


JOB TITLE

  • 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 may work collaboratively on one trial or across several trials to support clinical operations activities.

    Here’s What You’ll 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 within 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 the company

    Here’s What You’ll Bring to the Table:

    At least 5 five years of trial coordination experience in a clinical research and industry environment

    Advanced degree preferred or Bachelor’s 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 detail

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
#LI-TR1

SRGTalent
31/12/2021 12:00:00
USD 70.00 90.00 Hour
Contact Consultant:
Tyler Rostad

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