Clinical Trial Manager (Remote)
Company: SRG
Location: Nashville
Posted on: May 16, 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, Nashville , Clinical Trial Manager (Remote), Executive , Nashville, Tennessee
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