Clinical Project Manager II
Company: Intelliswift Software, Inc
Location: San Mateo
Posted on: November 22, 2021
Title: Clinical Project Manager II Location: Foster City, CA
- May support building Pop PK dataset and process flow, document
drafting, ClinPharm timeline in NDA/BLA
- Leads coordination of document drafting with Medical Writing,
Regulatory Project Management and the ClinPharm team and multiple
stakeholders and contributors
- Manages timelines based on submission plans and internal review
- Manages deliverables supporting submissions including Pop PK
Exposure Data, Pop PK Report, Summary modules, Part 11 Files used
to derive Pop PK data, etc. Education and Experience
- 5+ years relevant experience with BA/BS
- 3+ years relevant experience with MA/MS/MBA
- 0+ Years relevant experience with PhD, PharmD , or
- Where applicable, multiple years' project management experience
in life sciences, including multiple years' experience co-managing
- Where applicable, proven effectiveness managing project teams
in life sciences.
- Has complete knowledge of full cycle project management, from
project start-up to close-out.
- Has advanced knowledge of project management best practices and
tools and has shown ability to apply these to improve project
efficiencies and effectiveness.
- Has significant industry knowledge, including knowledge of drug
development, and is able to flex own knowledge to work on molecule
and/or non-molecule projects.
- Independently solves problems incurred and seeks advice when
needed. Ensures solutions are consistent with organizational
- Coaches less experienced team members in resolving problems.
Job Requirements:Skills: ClinPharm, Clinical Data,--Pop PK, Part 11
Keywords: Intelliswift Software, Inc, San Mateo , Clinical Project Manager II, Healthcare , San Mateo, California
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