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Clinical Project Manager (HEOR)

Syneos Health (Previously INC Research/inVentiv Health)

This is a Contract position in South Brunswick Township, NJ posted December 25, 2019.

(NOT IT)

Position: Sr. Clinical Project Manager

Location: Ridgefield, CT

Remote , work from home

Contract  offering Benefits

 **MUST have  HEOR experience**

JOB DESCRIPTION:

Degree Level    

•           BS in Life Sciences

 

Experience        

•           4+ years of PM experience in clinical operations with increasing levels of responsibility in the Pharmaceutical, Biotechnology, Medical Device, or CRO industry is required.

•           5+ years of clinical project management experience at sponsor or CRO company

  • health economics and outcomes research,  HEOR
  • knowledge of the different real world databases

 

TA Experience  

•           Oncology experience required

 

Key Skills, Major Responsibilities and Accountabilities    

•           Read, write and speak fluent English; excellent verbal and written communication skills

•           Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.

•           Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.

•           Provide efficient updates on trial progress with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.

•           Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.

•           Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

•           Ensure potential study risks are escalated to the attention of the CDP when appropriate.

•           Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.

•           Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.

•           Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team

•           Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner

•           Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.

•           Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures

•           Effectively provide support to Clinical Site Manager(s) in the conduct of the trials

•           Other duties as assigned