Clinical Pharmacology Project Manager
- Employer
- The Fountain Group LLC
- Location
- San Mateo, California
- Salary
- Commensurate with experience
- Posted
- Jan 06, 2025
- Closes
- Jan 23, 2025
- Ref
- 2870924543
- Focus Area
- Regulatory Writing, Other
- Position Type
- Individual Contributor
- Experience Level
- Experienced / Non-manager
- Work Mode
- Hybrid
- Organization Type
- Other
The Fountain Group are a national staffing firm and are currently seeking a Clinical Pharmacology Project Manager for a prominent Pharmaceutical client of ours. This position is in Foster City, CA. Details for the position are as follows:
Job Description:
Job Description:
- Pay: 55.00-59.00/hr.
- Length of Assignment: 6 month contract to start with potential for extension.
- Acts as the project manager for assigned projects of simple to moderate complexity.
- Develop and manage project plans, timelines, communications, meetings, and other interactions to ensure project deliverables are met on time, to the expected quality, and within budget.
- Oversee ClinPharm Subteams (CPSTs) and Protocol Concept Sheet development at the asset level, ensuring the execution of Clinical Pharmacology strategies to support program lifecycle management.
- May support the CliniPharm Submission Working Group (CSWG) by developing, coordinating and managing timelines for NDA/BLA submissions, leading cross-functional matrix teams comprising Medical Writing, Data Management, Regulatory Project Management, ClinOps, BioStats, and Clin Pharm team members.
- Manage submission-level ClinPharm deliverables and milestones aligned with submission strategies and the ClinPharm Review and Approval process. Key deliverables include QC/QA-ed PK data, PopPK data, E-R data, Pop PK reports, E-R reports, eSub packages, m2.7.1, m2.7.2, and other regulatory components.
- Interacts and collaborates with other functions; key stakeholders include Clin Pharm Lead, PMx lead, BioA lead, CPPM, Clin Ops, RPM, CDM, Medical Writing, and Regulatory Affairs)
- With support from the TA Project Management lead, creates and manages project budgets and resource plans for assigned projects.
- Knowledge of project management best practices and tools (SmartSheet, Timeline Pro and Visio) and has shown the ability to apply these to improve project efficiencies and effectiveness is nice to have, but not required.
Similar jobs
-
New