Clinical Trials Manager and Program Manager
Job Opportunity at Clinical Dynamix, Inc.

Posted on Aug 8

http://www.clinicaldynamix.com    888-558-2546

Job Type: Full Time
Job ID: W4112742

Top tier Pharmaceutical company (one n Boston and one in NJ nd one in Seattle)

Required:

Has completed management of a study or group of studies from planning through close out (Phase 3)

Experience with managing Vendors

Experience working on global studies with CROs

 

Nice to Have:

Experience supporting writing clinical study reports,

Supporting sNDA or NDA submissions,

Supporting pre-Inspection preparation,

Participating in Sponsor Inspections by Regulatory Bodies

Experience managing or leading teams at a project level or a activity within an activity

 


interface with director of clinical and drug development to effectively move program along
Primary interface with drug development and clinical operations at the Program level
•Works at the direction of the Dir Clinical to ensure an integrated approach to scientific oversight and operational execution a clinical programs to ensure that objectives are met and delivered in line with timelines, cost and quality metrics
•Helps Identify clinical issues within and across studies within a program
Executional Excellence  and Team Function
•Monitors team performance, and quality metrics across programs ; identifies issues and partners with Dir CPM to develop appropriate action plans
•Works with Dir Clinical to ensure process alignment for medical/scientific review and GCP quality and regulatory compliance
•Supports completion of Clinical Development Plans  (CDPs) across for and alignment with other relevant plans (e.g. SDP).
•Tracks program budget across  in partnership with the Director, CPM
•May support due diligence activities at the direction of  Dir CPM and TAH
Maximizes effectiveness
•Supports the development/application of standardized processes, methodologies, appropriate metrics and  to systematize continuous process improvement and impart best practices across TA to maximize effectiveness
•Advanced degree (BA/BS, Master’s, PharmD, PhD) , preferably in life sciences/health-related field or commensurate work experience.
•5-8 years of pharmaceuticals/biotech experience- ideally need oncology and people management experience
•3+ years drug development experience in the pharmaceutical industry, biotech, CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
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