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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Senior Clinical Trial Manager
Remote, CA US
Posted: 06/10/2025
2025-06-10
2025-07-15
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 4471
Job Description
The Senior Clinical Trial Manager (CTM) is responsible for the day-to-day management of a clinical trial or region, oversight of vendors, and clinical trial sites.
For this study, the role is as a Lead Study Manager.
The Senior Clinical Trial Manager (Sr. CTM) is accountable for ensuring high quality deliverables are within timelines and budget. This position will work closely with cross-functional teams to ensure study start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials.
Responsibilities:
For this study, the role is as a Lead Study Manager.
The Senior Clinical Trial Manager (Sr. CTM) is accountable for ensuring high quality deliverables are within timelines and budget. This position will work closely with cross-functional teams to ensure study start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials.
Responsibilities:
- Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc. for assigned region(s) or study(s)
- Manages high-impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)
- Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc.
- Lead, or actively contribute to, Study Management Team meetings
- Identify study risks, develop and implement mitigation strategies
- Oversee Trial Master File, Completeness Reviews, and Essential Document List
- Support the study budgeting process, including the review of clinical trial financial accruals
- Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
- Typically, 8 years of direct work experience in Clinical Research, with international experience
- Experience in study start up and management (Sponsor) of post marketing studies preferred
- Fully capable to independently lead all aspects of a clinical trial
- Effective leadership of cross-functional teams
- Excellent planning, organizational, and communication skills
- Able to handle multiple tasks and deadlines, and identify risks and issues and take appropriate actions
- Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter-organizational impact
- Must have the ability to build and maintain positive relationships with management, peers, vendors, and clinical sites
- 10% travel may be required