Clinical Project Manager - Nephrology - new job in Cincinnati, US

Clinical Project Manager - Nephrology
  • Competitive
    HOUR
  • Temporary
  • Cincinnati MA, US Cincinnati MIDDLESEX US
Job Ref: JO000132238
Sector: Clinical
Sub-sector: Project Management
Date Added: 01 August 2022


Clinical Trial Manager - Nephrology

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.

#LI-TR #LI-REMOTE

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
31/08/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Tyler Rostad

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