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Clin PM (device)
WASHINGTON DC 20001
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90562743

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  Job posted:   Tue Jun 5, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Clin PM (device)
Job Description:
The role of the Clinical Trial Manager is to provide leadership and project management for clinical trial activities. The Clinical Trial Manager is responsible for managing the planning, implementation, and tracking of clinical monitoring processes, administration of clinical trials and maintaining an overview of the clinical trials. The position requires an active role in overseeing the monitoring, data and safety plans. The candidate must have extensive experience interacting effectively with investigators and cross-functional teams. This position will report to the company's Director of Clinical Affairs.
* Ensure that Phase 1-4 clinical studies are properly resourced, managed and executed in accordance with established timelines and quality standards.
* Ensure that studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
* Provide operational and strategic input and/or approves study documents such as clinical protocols, ICFs, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manuals, Patient Diaries, Study Reference Binders, Pharmacy Manuals, Clinical Data Review Plans, clinical database specifications, Clinical Study Reports (CSR), etc.
* Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
* Lead and direct project team to ensure deliverables meet project timelines.
* Track and report on progress of study including site activation, patient enrollment, and monitoring visits.
* Develop Clinical Monitoring Plan and other project documents as assigned.
* Manage clinical monitoring functions of clinical studies.
* Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
* Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
* Oversee study vendors, when applicable.
* Provide ongoing study training to the clinical project team.
* Assist with professional development for Clinical Research Associates and Clinical Associates.
* Maintain knowledge of current GCP, FDA, and other applicable regulations.
MUST-HAVES:
* BA/BS or equivalent degree in scientific discipline. Advance degree preferred (MA/MS, PharmD, PhD).
* Device experience mandatory
* Overall PM experience -> 4-5 years minimum
* CRA experience->5 years
* CRO experience->2-3 (Personally, I like to see big-CRO experience)
* Experience managing a team of at least 5 CRAs
* Strong communication skills/capable of being sponsor-facing
* CRF design experience
* Protocol development experience
* ICF development experience
* Ability to work on 3-5 protocols at any given time
* Ability to travel 10-20%
Please send resume to jobs@inventivhealth.com
*Min Salary:* $0.00
*Max Salary:* $0.00
*State:* DC

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