1+ months

Sr Clinical Trial Manager

Kelly Services
Alameda, CA 94501
**Sr Clinical Trial Manager**

Plan, manage and oversee trials including internal and external staff. Responsibility for CRO oversight. Train, coordinate and performance reviews on direct reports.

**Responsibilities** :

Manage clinical trials that are conducted through CROs including performance assessment

Act as facilitator, set agendas, study team meetings

Primary contact for vendors

Responsible for protocol execution of trials

Interact cross functionally with other departments within the organization such as Regulatory Affairs, Drug Safety, etc.

May help in development of study protocols, ICF, CRF and other study/monitoring tools

Establish, track and report of study metrics

Responsible for Trip Report Review, TMF review, co-monitoring visits and provide documentation of all issues and findings

Co-monitor sites with up to 25% travel

Pre-visit site selection, site initiation visit, interim monitoring visit and close out visits

Assist with other vendor types such as labs

Protocol operational feasibility assessment

Assist in preparation for regulatory inspections

Review IRB approved informed consent forms

Study guide and subject instruction preparation

Ensure compliance with policies and SOPs

May assist with preparation of study reports, IND safety and clinical summaries

May supervise staff

**Requirements** :

BA/BS in biological sciences or related field

9 years in biotech/pharma industry with 4 years in clinical operations including knowledge of regulations and guidelines

Expertise in clinical development studies

Preparation of IND, BLA or NDA

Management of multinational clinical trials

Experience in all phases of drug development, including international trials

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 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 careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at


Posted: 2019-09-09 Expires: 2020-02-08

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Sr Clinical Trial Manager

Kelly Services
Alameda, CA 94501

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