Clinical Trial Manager - Phase I
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 3 years of clinical project management experience in the CRO or pharma industry.
- Experience in leading Phase I clinical trials.
- 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.
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