Position Overview

Umoja is looking for an experienced Senior Clinical Project Manager who supports planning and execution of clinical trials with the primary focus on facilitating cross-functional Study Team activities, establishing and maintaining project milestones, timelines, forecasts, and managing/overseeing Clinical Research Organization (CRO) for early phase trial activities.

The candidate will ideally have a background in biologics and/or cellular/genetic therapies. Experienced, independent clinical operations lead who have worked with cross- functional program teams in the past and are looking for an exciting challenge with a novel therapeutic platform at a growing company and be a part of the next generation of cancer therapies should apply.

The applicant could be local to the Seattle area or elsewhere in the US.

CORE ACCOUNTABILITIES
Specific responsibilities include:

• Drives all aspects of the project management process from clinical trial planning, execution, control, and closure.
• Establish and maintain comprehensive cross-functional study timelines and collaborates with the cross functional clinical trial study team and CRO(s) for trial operational delivery to ensure timelines are met.

• Develop comprehensive clinical study budgets in partnership with the cross -functional study team members and provides oversite to ensure clinical studies remain within established budgets.
• Develops enrollment projection, and drug supply needs as part of the budget.
• Initiate and facilitate Requests for Proposal and Requests for Information Procure.
• Manage, and oversee CROs, Central Laboratories and other vendors.
• Ensure quality and compliance of clinical trials with local regulatory requirements; overall data integrity; and human subject protection.
• Contributes to the development and implementation of study design, IB, protocols and various cross-functional study plans and materials including but not limited to CRO oversight plans, vendor oversight plans, communication plans, data management plans, safety management plans, and IND safety report distribution.
• Identify potential risks to successful clinical trial execution and develop and institutes mitigation plans.
• Prepare and present timely status updates and performance metrics to leadership, project teams, and main stakeholders.
• Effectively communicate and interface between numerous internal functional groups, the CRO and vendors to ensure apt communication and strong relationships.
• Aid in developing clinical operations standard operating procedures (SOPs).
• Manages/reviews/approves vendor invoices, accruals, and SOW changes.

The successful candidate will have:

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with a minimum of 6 years of prior clinical work experience and a minimum of 2 years project management experience. Note: an equivalent combination of education and experience will be considered.
• Knowledge and experience using project management methodologies and tools.
• Experience developing comprehensive study/project timelines.
• Experience forecasting and managing project budgets.
• Experience managing CROs and other study vendors such as central labs, IRT, and database systems.
• Excellent written and verbal communication skills.
• Ability to influence and reach compromises cross functionally.
• Good understanding of other cross-functional departments/disciplines and how they contribute to the drug development process.
• Expert knowledge of FDA regulations, ICH guidelines, Good Clinical Practices (GCP) and the drug development process.
• Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment.

Preferred Qualifications:

• Background in oncology drug development is strongly preferred.
• Background in cell or gene therapy drug development is strongly preferred.
• Project management training certification preferred.
• Highly effective written/verbal communication skills Proficiency with MS Word, Excel, Outlook, PowerPoint, SharePoint, OneNote Demonstrated Proficiency with SmartSheet and/or MS project preferred.

Physical Requirements:

• Ability to travel as needed. Approximately 10% travel.

Salary Range: $133,450 - $172,700