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.
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 firstname.lastname@example.org
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.