Senior Clinical Project Manager
Senior Clinical Project Manager
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Salary Not Disclosed
1 Vacancy
Job Description
The Senior Clinical Project Manager reports directly to the Director Clinical Affairs and plays a critical role within TMC. This individual will lead all of the Companys clinical research projects including strategy and budgetary planning and management.
As the Clinical Affairs Project Manager you will work closely with the Companys marketing staff KOLs investigating physicians and clinical research operations personnel (contractors) to manage all aspects of the companys clinical studies including assessing operational feasibility and recommending study plans; developing and managing comprehensive study timelines and metrics; overseeing the selection and management/oversight of external vendors while developing vendor specifications; reviewing vendor reports budgets and metrics; preparing and presenting project debriefings as required; planning executing and leading studyspecific meetings; and managing/participating in sitemonitoring visits.
You will be a handson leader and the point of contact for clinical trial sites. Will monitor and drive enrollment in studies provide site screening and initiations and interact directly with contracted monitoring and data management organizations where utilized. You may also be involved in preparation of submissions to the FDA.
What you will be responsible for:
Manage and oversees multiple clinical studies and the multidisciplinary clinical study team
Identify clinical sites and establishes relationships with potential Principal Investigators
Work directly with customers to validate the clinical value of the product (work on ongoing trials and initiate trials with customer)
Support clinical researchrelated procedures
Develop Protocols informed consent forms and other clinical study documents
Prepare IRB submissions to obtain the necessary approvals
Ensure study implementation including site staff training data collection and oversees study progress
Perform study monitoring visits (qualification initiation interim and closeout) as needed
Review and approve of study monitoring visit letters and reports
Perform data analysis generates reports and archives data
Provide feedback to product management for User Requirements generation and validation based on interfacing with clinical users
Create and tracks clinicals study plans and budgets
Ensure compliance with regulations (e.g. FDA ISO ICH) and Good Clinical Practices (GCPs)
Qualifications :
Bachelors degree
Seven 7 years of experience as Clinical Research Associate actively monitoring clinical research projects.
Seven 7 years of experience as a Program/project manager and/or process improvement in clinical research or healthcare
Experience in MS Project (or similar scheduling software) Smart Sheets project management techniques and tools Excel PowerPoint and Word
Project Management Professional (PMP) Project Management Certification (preferably PMI) a plus
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Treaces Privacy Policy
It is Treaces policy not to discriminate against any applicant for employment or any employee because of age color sex disability national origin race religion veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer
Treace is a drug free employer.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Business Development
- Project Management Methodology
- Project / Program Management
- PMBOK
- Waterfall
- Wastewater
- Construction Management
- Project Management
- Project Management Software
- Microsoft Project
- Budgeting
- Contracts
