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ASSOCIATE DIRECTOR, CLINICAL OPERATIONS job in West Conshohocken at The Judge Group

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ASSOCIATE DIRECTOR, CLINICAL OPERATIONS at The Judge Group

ASSOCIATE DIRECTOR, CLINICAL OPERATIONS

The Judge Group West Conshohocken, PA Full-Time
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Location: West Conshohocken, PA
Description: Our client is currently seeking a ASSOCIATE DIRECTOR, CLINICAL OPERATIONS

This job will have the following responsibilities:
•Collaborate with cross-functional counterparts to oversee the performance for all activities to deliver programs on time and with quality. 
•Accountable for the operational delivery of CPMs and their programs, ensuring all program deliverable and milestones are met with quality and within budget. 
 •Participate in program strategy meetings, contributing the operational strategy of program/studies. 
•Provide direction and support to CPMs for the development of study strategy operational plans including enrolment models and risk management strategy. Ensure consistent approach and process across the portfolio.
•Review and provide expert clinical operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, monitoring plans, Communication plans and project plans. 
•Support efforts for the selection and oversight of external service providers, including Contract Research Organizations (CROs) and other vendors as necessary. 
•Review of study protocols and related study documents, as required, for operational execution. 
•Oversight of team's study execution and procedures as required to ensure regulatory compliance of protocol activities. 
•Support Clinical Program budget negotiations and management of Clinical Operations spend related to clinical program execution. Works closely with Global Project Managers, Outsourcing Management, and Finance to ensure on a regular basis that budgets are accurate. 
•Play an active part in CRO selection and review of RFP's when required, ensuring the appropriate CRO is identified and properly vetted. Work with internal and external teams


Qualifications & Requirements:
•Worked to fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes. Supporting and influencing key stakeholders where required for the successful delivery of projects. 
•Provided a strong clinical operational focus whilst being able to identify program needs and deliver practical, straight-forward, solutions which work first time. 
•Vendor Oversight experience. 
•Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
•Demonstrated excellence in project/program management and matrix leadership. 
•Understands and applies the principles of GCP, ICH, GDP and relevant CFRs is required.

Contact: [ Link removed ] - Click here to apply to ASSOCIATE DIRECTOR, CLINICAL OPERATIONS
This job and many more are available through The Judge Group. Find us on the web at [ Link removed ] - Click here to apply to ASSOCIATE DIRECTOR, CLINICAL OPERATIONS

Recommended Skills

  • Clinical Research
  • Clinical Study Reports
  • Clinical Works
  • Coaching And Mentoring
  • Drug Development
  • Finance
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Job ID: 836728

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