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Clinical Trial Manager (Remote)

Company: SRG
Location: Raleigh
Posted on: May 15, 2022

Job Description:

Job Overview

SRG is a Global Life Sciences staffing and consulting firm is currently seeking several home-based, Clinical Trial Project Managers . The Clinical Project Manager - manages and coordinates clinical project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed.

Essential Job Functions
Performs project oversight in compliance with applicable Clinical policies, regulations, international standards, and SOPs
Applies thorough understanding of FDA Guidelines, ICH, GCP, and other applicable regulations in overseeing all aspects of clinical research projects (primarily inclusive of complex, full-service and/or global trials) to ensure sponsor requirements are met
Perform contract and financial management activities for assigned trials and serve as central point of contact with sponsor for project updates
Meet with resourcing lead and supervisor to assure project needs are adequately met for all assigned projects
Participate in business development activities, including proposal development and pricing and bid defense meetings, as required
Responsible for the management of US and Global projects, and displays very strong customer relations skills
Responsible to organize Kick Off Meeting, internal and sponsor meetings, draft meeting agendas and review/approve meeting minutes
Position requires careful management of budgets in order to maximize project profitability
Provides operational support for Clinical Operations
Demonstrates problem solving ability, taking into consideration sponsor deadlines as well as financial, quality and other important project aspects
Ability to work with minimal supervision; able to confidently make project decisions that could have substantial impact on clinical, data quality, or regulatory issues
Contributes to the overall operations and to the achievement of departmental goals

What You Will Need
Bachelor\'s degree in a life sciences discipline desired or equivalent training and experience
Must have a minimum 5 years of clinical project management experience in the CRO or pharma industry.
Experience in leading multi-service project teams through a complete clinical trial or multiple trials at various stages is required.
Good knowledge of clinical, regulatory, and data aspects of trials including, but not limited to field monitoring, data management, biostatistics, and medical writing
Advanced knowledge of FDA guidelines and review processes, ICH/GCP compliance and regulations. Knowledge of IND and NDA process preferred.
Project management skills including client management, fiscal/contract management, cohort and vendor management, quality management is required; as well as strong time management skills and the ability to thrive in a fast-paced environment with multiple priorities
Solid Microsoft Office Suite (Word, Excel, Powerpoint) as well as experience with tools specific to clinical trial management (e.g. CTMS, EDC, IVRS, eTMF, etc.)
Effective leadership skills, with the ability to manage multiple stakeholders
Effective verbal and written communication skills leading to successful team collaboration

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

Keywords: SRG, Raleigh , Clinical Trial Manager (Remote), Healthcare , Raleigh, North Carolina

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