Clinical Program Lead: Trials & CRO Oversight (Temp to Perm)

Protara Therapeutics, Inc.

Oregon

Hybrid

USD 94,000 - 107,000

Full time

7 days ago
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Job summary

Protara Therapeutics, Inc. is seeking a Clinical Project Manager, Temp to Perm, to support the Clinical Operations team across ongoing programs.

The role involves coordinating CROs, regulatory submissions, safety reporting, and site monitoring with a focus on ensuring inspection readiness and smooth study execution. Qualifications include a bachelor's degree in clinical research or life sciences and at least 5 years of trial management experience, with familiarity in ICH/GCP/CFR guidelines and

Qualifications

  • Bachelor's degree in clinical research, life science or related field.
  • 5+ years of relevant clinical trial management experience in pharma/biotech.
  • Knowledge of ICH, GCP and CFR guidelines.

Responsibilities

  • Serve as secondary clinical operations contact for one or more trials.
  • Liaise with Regulatory for submissions and safety reporting.
  • Support CRO selection, LOI, SOW and budget reviews.
  • Manage study eTMF and inspection readiness.
  • Oversee financials: CRO invoicing, budgets and invoices.
  • Interact with CROs, sites, investigators, coordinators, pharmacists, and Protara staff.
  • Travel to clinical sites as needed (up to 30%).

Skills

ICH/GCP/CFR knowledge
EDC platforms experience
MS Office proficiency
Clinical trial monitoring knowledge
Smartsheets familiarity

Education

Bachelor's degree in clinical research or life sciences

Tools

Smartsheets
EDC platforms

Job description

Protara Therapeutics, Inc. is seeking a Clinical Project Manager, Temp to Perm, to support the Clinical Operations team across ongoing programs.

The role involves coordinating CROs, regulatory submissions, safety reporting, and site monitoring with a focus on ensuring inspection readiness and smooth study execution. Qualifications include a bachelor's degree in clinical research or life sciences and at least 5 years of trial management experience, with familiarity in ICH/GCP/CFR guidelines and

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