Project Manager
 Advanced Clinical | |
 United States, California, Foster City | |
 Jan 12, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Project Manager in Foster City, CA. The Project Manager of Clinical Pharmacology role develops and manages project plans, timelines, communications, meetings, and other interactions to ensure project deliverables are met on time, to the expected quality, and within budget. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES * 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. * Oversee the ClinPharm portfolio and operations, including developing and maintaining CPPM SharePoint sites, templates, processes, and workflow diagrams. * Leads simple to moderately complex assignments that enable multiple functions and teams to achieve their project objectives within targeted timelines and allocated resources. * Leverages past precedence and Clin Pharm PM best practices to advise other functions on how to best achieve their project goals and objectives. * 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) * Collaborates and partners with others across Development to ensure assigned projects are completed on time, within budget, and to the expected quality. * Manages task assignments and output quality of others supporting their projects. * Provides matrix management to project teams supported. Typically manages multiple teams simultaneously. * With support from the TA Project Management lead, creates and manages project budgets and resource plans for assigned projects. * Support identifying cross-project synergies to leverage efficiencies and ensure consistencies where appropriate. * Leads simple to moderately complex projects that enable Development initiatives to proceed. * Contributes to CPPM best practices and improvements. * Identifies cross-project synergies that accelerate our progress and maximize efficiencies. EXPERIENCE & EDUCATION * 5+ years relevant experience with BA/BS * 3+ years relevant experience with MA/MS/MBA * 0+ Years relevant experience with PhD, PharmD, or equivalent To be a best-fit your strengths must include: * Knowledge of full-cycle project management, from project start-up to close-out. * Knowledge of project management best practices and tools (SmartSheet, Timeline Pro and Visio) and the ability to apply these to improve project efficiencies and effectiveness. * Significant industry knowledge, including knowledge of drug development, and can flex own knowledge to work on molecule and/or non-molecule projects. * Independently solving problems incurred and seeks advice when needed. Ensures solutions are consistent with organizational objectives. * Coaching less experienced team members in resolving problems. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |