Clinical Trial Manager, Clinical Operations, Infec

Clinical Trial Manager, Clinical Operations, Infec
  • Competitive
    HOUR
  • Temporary
  • CAMBRIDGE MA, US CAMBRIDGE MIDDLESEX US 02139
Job Ref: JO000124578
Sector: Science
Sub-sector: Food & FMCG
Date Added: 30 November 2021


Clinical Trial Manager
JOB DESCRIPTION

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 in accordance with the Company 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 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

#LI-BH1

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.

SRGTalent
03/12/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Brian Houston

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