Clinical Trial Manager

SUMMARY

Reporting to Clinical Operations Management, the Clinical Trial Manager will be responsible for the successful execution of clinical trials from study startup through delivery of the clinical study report, ensuring completion of study deliverables, and proactively identifying and resolving clinical project issues.  The Clinical Trial Manager will help to ensure completion of study deliverables by proactively identifying and escalating clinical project issues.

Specifically, the Clinical Trial Manager will:

  1. Serve as primary contact for functional area representatives.
  2. Develop trial plans.
  3. Develop creative strategies for site monitoring, risk mitigation, site selection, and clinical supplies management.
  4. Manage study milestones to ensure accurate tracking and reporting of study metrics.
  5. Perform service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  6. Create and manage clinical trial budgets.
  7. Assist with remote/centralized monitoring.
  8. Travel to perform sponsor oversight of clinical research units and vendors.
  9. Provide study-specific direction to external team members.
  10. Communicate study updates to stakeholders, including executive team.
  11. Observe all Trevena policies, SOPs and safety guidelines.
  12. Collaborate with Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance and observance of SOPs and ICH/GCPs.
  13. Perform other duties as required.

TRAVEL REQUIREMENTS

Up to 25% domestic/international travel.

EDUCATION & EXPERIENCE

  1. Bachelor’s degree (in Science preferred).
  2. 3 years research/trial management experience (which can include academic, CRO and/or industry).
  3. Monitoring experience (preferred).
  4. CNS experience (preferred).

KNOWLEDGE, SKILLS & ABILITIES

  1. Broad and current knowledge of regulations and clinical development process.
  2. Proven leadership skills required to ensure timelines, budget and quality metrics are met.
  3. Effectively disseminate information cross-functionally.
  4. Excellent organizational and negotiation skills.
  5. Proven ability in creative problem-solving.
  6. Team-oriented and collaborates effectively.
  7. Proficient computer skills, specifically with Word, Excel, PowerPoint, and Outlook.
  8. Knowledge of EDC and IRT or similar systems.

Apply Now

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc