Senior Clinical Study Manager

Senior Clinical Research Study Manager

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 oversight 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