Trevena, a publicly-traded, clinical stage biopharmaceutical company located in Chesterbrook, Pennsylvania is looking for a Clinical Trial Manager to join our team. Reporting to the Director, Head of Clinical Operations, 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. Work effectively in an open office environment.
14. Perform other duties as required.
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Trevena does not accept unsolicited assistance from staffing or search firms for this or any other employment opportunity. Please, no phone calls or emails. All resumes submitted by staffing or search firms to any employee at Trevena via email, the Internet, in person or in any form and/or method without a valid, written and executed search agreement in place for this position shall be deemed the sole property of Trevena and no fee or other payment shall be paid in the event that the referred candidate is hired by Trevena.
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