At Talosix, we believe that every study should be treated as though lives depend on it. This mission drives us to break down the barriers and bloat in clinical research by using a strategic combination of technology and services.

We seek to achieve this mission through the development of intelligent products, solutions and platforms that address the sticking points contributing to long timelines and excessive budgets. Our team comprises seasoned entrepreneurs, clinical research experts, machine learning specialists, and data engineers all unified in achieving Talosix’s vision.

Talosix is headquartered in the cloud capital of the world, Seattle, WA.

Position Overview:

We are looking for a data-driven, Senior Clinical Study Manager with a strong clinical research background to manage and support multiple studies. The role will support the planning and execution of clinical trials with a primary focus on facilitating cross-functional Study Team activities while establishing and maintaining project milestones, timelines, forecasts, and managing/overseeing 3rd parties.

The ideal candidate:

• Has experience across multiple phases of clinical trials and real-world evidence studies, performing overall study management from start-up through close-out

• Is an independent, proactive clinical operations leader who has worked with cross- functional research teams

• Has a background in clinical research and/or pre-clinical. Experience in the pharmaceutical, bio-pharmaceutical and oncology space would be beneficial

• Is local to the Seattle area.

CORE RESPONSIBILITIES

Clinical Research

• Drive all aspects of the study management process from planning, execution, control, and close-out. Assist in requirements gathering and translate to best-in-class data collection and reporting outputs

• Contribute to the development and implementation of study design, IRB submissions, case report forms (CRFs), protocols and various cross-functional study plans, data collection design, data dictionaries, and materials including but not limited to vendor oversight plans, communication plans, data management plans, and safety management plans

• Develop comprehensive clinical study budgets in partnership with the cross -functional study team members and provide oversite to ensure clinical studies remain within established budgets

• Develop enrollment projection, and inventory supply needs as part of the budget.

• Establish and maintain comprehensive cross-functional study timelines and collaborate with the cross functional clinical trial study team for trial operational delivery to ensure timelines are met

• Manage, and oversee 3rd party vendors such as central laboratories

• Ensure quality and compliance of clinical trials with local regulatory requirements; overall data integrity; and human subject protection

• Monitor data quality and ensure appropriate actions are taken to achieve optimal data integrity

• Identify potential risks to successful clinical trial execution and develop and institute mitigation plans

• Prepare and present timely status updates and performance metrics to leadership, study teams, and main stakeholders

• Effectively communicate and interface between numerous internal functional groups, the Sponsors, Sites, PI’s and vendors to ensure proactive communication and strong relationships

• Assist in developing clinical operations standard operating procedures (SOPs)

• Manage/review/approve vendor invoices, accruals, and Scope of Work (SOW) changes

• Oversee & utilize Talosix's products to drive & enable successful clinical studies for clients

Study Manager

• Primary point of contact and escalation point for clients

• Task/Milestone/Deliverable planning, prioritization, tracking and reporting

• Independently coordinate and prioritize multiple projects in a fast-paced environment

• Ability to influence and reach compromises cross functionally

• Experience developing comprehensive study/project timelines and managing to them

• Demonstrated ability to identify and solve issues/risks broadly while diving into the details

• Responsible to achieve contract and client expectations within target budgets

• Experience forecasting and managing project budgets

• Drive invoicing and reimbursement schedules with all clients

• Train and support all users on the Talosix product

• Assist with new business development activities by drafting scopes, proposals and presentations

• Identify needs across the business and proactively provide solutions

Qualifications

• 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

• 4+ years of prior clinical and/or pre-clinical research experience across the phases of clinical trials

• Experience applying technology solutions in clinical research (e.g. EDC, CTMS, trial supply management, etc.)

• Expert knowledge of FDA regulations, ICH guidelines, HIPAA, Good Clinical Practices (GCP)

• Must have a start-up mentality:

• Be an owner (accountable, results-driven and motivated to succeed)

• Mobilize on a strategy and achieve results quickly and proactively

• Understand the business impacts of decisions

• Thrive in an “all-hands-on-deck” type environment

• Takes ownership of projects

• Be accountable and decisive

• Background in oncology research is strongly preferred.

• CRO Services experience a plus!

• Project management training certification preferred (PMP a plus)

Skills

• Must be comfortable managing client relationships and collaborating with multiple levels within an organization

• Excellent attention to detail and the ability to keep detailed, accurate records

• Must possess superior analytical and creative thinking skills

Join the Team! To apply, please send your resume to recruiting@talosix.com