Kelly Services Clinical Trial Manager/Senior Manager in Seattle, Washington

Clinical Trial Manager/Senior Manager—Seattle, WA

As a member of the Clinical Development Team, the Clinical Trial Manager/Senior Manager will work closely with internal team members and vendors, as well as clinical study sites ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets. You’ll have responsibility for managing the operational aspects of clinical.

Job Duties and Responsibilities:

  • Participating in protocol, CRF and strategy development, Clinical Study Report preparation, and NDA submission.

  • Proactively identifying potential study issues/risks and recommending/implementing solutions CRO/vendor activities including:

  • Participating in and facilitating the CRO/vendor selection process for outsourced activities.

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

  • Working with the CRO to develop and revise scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations are met.

  • Preparing, reviewing, and approving study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual and CRF Completions Guidelines).

  • Managing clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.

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

  • Preparing metrics and updates for the Clinical Development Team.

  • Recommending and implementing innovative process ideas to positively impact clinical trials management.

  • Organizing and managing internal team meetings, investigator meetings and other trial-specific meetings; serving as a liaison and resource for investigational sites.

  • Reviewing site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments.

  • Participating in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function.

Job Requirements:

  • B.S. Degree in Life Sciences and 5+ years of related clinical trial management experience, with a minimum of 2 years of supervisory experience.

  • Experience in interactions with outside CROs and other vendors.

  • Familiarity with the advanced concepts of clinical research.

  • Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.

  • Experience providing clinical operations expertise to clinical development in a specified project or project area.

  • Experience with automated liquid handling instruments is a plus.

Apply Today! Questions? Call Justin at 714.602.1217 or email your resume to justin.lynn@kellyscientific.com

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.