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Kelly® Science & Clinical is seeking a Clinical Trial Manager for a fulltime, contract-to-perm position with a biopharmaceutical client in Seattle, WA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Clinical Trial Manager

Full-Time: contract-to-perm, w/full benefit package

Hybrid, Seattle, WA

Relocation assistance is not available.

Summary: Our client, based in Seattle, is a privately held, clinical-stage, fully integrated biopharmaceutical company. Founded in 2017 with a vision to use genetically engineered spirulina - photosynthetic, edible algae – for manufacturing and delivering biologic drugs. Our client uses the spirulina platform for gastrointestinal, airway, and topical delivery of therapeutic proteins, including antibodies, bioactive peptides, enzymes, cytokines, and vaccine antigens. Therapeutic areas of interest encompass infectious diseases, cardiometabolic diseases, inflammatory diseases, and enzyme deficiencies.

The Clinical Trial Manager will play a vital role in management and oversight of the clinical operations activities within a growing biopharmaceutical company. This position requires strong leadership skills, in-depth knowledge of clinical research processes, and strong understanding of ICH GCP and FDA medicinal product development regulations. The Clinical Trial Manager will be responsible for ensuring the successful execution of clinical trials, adherence to regulatory guidelines, and the timely delivery of high-quality clinical data.

Essential Duties and Responsibilities:

• Oversee all operational aspects of infectious disease clinical trial(s)

• Oversee the clinical trials including study start-up, enrollment, study conduct, close-out and the clinical study report (CSR) process

• Prepare and review study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)

• Provide oversight and guidance if some tasks are delegated to a member of the Clinical Operations team

• Participate in study strategy development, Line Listing Review, and CSR preparation

• Manage the study project plan, including timelines and budget

• Provide training and manage CRO vendors such as IVRS, Depots, Central labs, Imaging

• Work with CRO to develop and revise study-specific plans and detailed timelines and ensure that transferred obligations and performance expectations are met and documented

• Further manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)

• Create and implement corrective action plan when performance expectations are not being met

• Coordinate internally and externally with multiple stakeholders when patients are identified, samples are collected and delivered to testing labs

• Proactively identify potential study issues/risks and recommends/implements solutions

• Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function

• Prepare metrics and updates for management, as assigned

• Organize and manages internal team meetings, investigator meetings and other trial-specific meetings

• Review site study documents (informed consent template and study tools/worksheets)

• Serve as a liaison and resource for investigational sites

• Participate in the development, review and implementation of departmental SOPs and processes

• Attend cross-functional meetings as needed to represent Clinical Operations and study-specific issues

• Provide mentorship and career development to team members

• Includes other duties and responsibilities as assigned. Duties and responsibilities may be modified or changed at any time based on the needs of the business.

Basic Qualifications:

• Bachelor of Science with ten (10) years of experience, or Master of Science with six (7) years of experience, or Ph.D. with three (5) years of experience or equivalent amount of education and experience.

• Experience should demonstrate progressive responsibility and success in clinical operations and trial management.

Preferred Qualifications:

• At least 7 years of clinical trial management experience on the sponsor side

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology

• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management

• Highly developed leadership skills to successfully lead a clinical study team

• Must be willing to travel at least 10% (possibly more)

• Ability to deal with time demands, incomplete information or unexpected events

• Must display strong analytical and problem-solving skills

• Attention to detail and quality in documentation practices

• Outstanding organizational skills with the ability to multi-task and prioritize

• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment

• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

• Ability to be part of the team as well as step in to lead.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.