Biotech Clinical Project Manager — Fast-Paced Trials

Protara Therapeutics, Inc.

New York (NY)

Hybrid

USD 94,000 - 107,000

Full time

11 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 our NMIBC and LM projects.

The role includes acting as a secondary operations contact for trials, ensuring CROs meet deliverables, and managing eTMFs with an eye toward inspection readiness. The successful candidate will liaise with Regulatory, Safety, and cross-functional teams, manage study budgets and CRO oversight, and contribute to enrollment strategies while

Qualifications

  • Knowledge of ICH, GCP, and CFR guidelines.
  • Experience with different EDC platforms.
  • Proficient in MS Office Suite.
  • Knowledge of the clinical trial monitoring process.
  • Smartsheets knowledge preferred.

Responsibilities

  • Serve as the secondary clinical operations contact for one or more trials.
  • Coordinate with Regulatory, Safety, and cross-functional teams for submissions and DSURs.
  • Review bid-defense proposals, LOIs, SOWs and budgets; assist in timeline development.
  • Support vendor selection, onboarding and management throughout the study life cycle.
  • Oversee study eTMF and ensure inspection readiness across trials.
  • Travel up to ~30% to clinical sites, vendors, and NY office as needed.

Skills

ICH/GCP/CFR guidelines
EDC platforms
MS Office
Clinical trial monitoring
Smartsheets

Education

Bachelor's degree in clinical research or life sciences

Job description

Protara Therapeutics, Inc. is seeking a Clinical Project Manager, Temp to Perm, to support the Clinical Operations team across our NMIBC and LM projects.

The role includes acting as a secondary operations contact for trials, ensuring CROs meet deliverables, and managing eTMFs with an eye toward inspection readiness. The successful candidate will liaise with Regulatory, Safety, and cross-functional teams, manage study budgets and CRO oversight, and contribute to enrollment strategies while

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