21 days old

Senior Manager, Clinical Operations

Kelly Services
Fremont, CA 94536
**_Senior Manager, Clinical Operations_**

**Job Description**

A world leading medical technology company, dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies. We are currently seeking a Senior Manager, International Clinical Operations to join our Neurovascular Division.

As Senior Manager, International Clinical Operations, you will lead globally to deliver large clinical studies. You will design and execute complex international studies to demonstrate safety and effectiveness of products. You will manage global clinical project team members to complete their projects on time and with efficiency and high data quality. You will also collaborate with internal and external partners to create clinical presentations and publications.

+ Be accountable for concurrent global clinical studies as part of a therapeutic program.

+ Use resources, expertise, and knowledge across projects to ensure completion of project deliverables.

+ Hire, train, develop, mentor, and supervise Clinical Project Managers and staff. Develop staffing plans for therapeutic area by region.

+ Participate in developing global strategies for therapeutic areas with Regulatory, Marketing, R&D, and Reimbursement.

+ Oversee budgets and resources and ensure project managers manage project budgets.

+ Oversee and provide input to study protocols and other study documents.

+ Provide oversight of trials to ensure safety concerns are identified, managed, and reported.

+ Manage data release meetings for trials and approve final reports.

+ Represent Clinical on New Product Development teams.

+ Coach others in applying clinical research laws, regulations, standards, and compliance with applicable SOPs and policies.

**What you need**

+ A minimum of a Bachelors Degree (B.S. or B.A.) required; preferably with a life science focus.

+ A Masters degree in business management a plus.

+ A minimum of 10 years of clinical research experience (device, pharmaceutical or biotechnology) required.

+ Proficiency in resource and trial budget planning required.

+ Experience with working with CROs required, preferably in EMEA or Asia Pacific.

+ Previous people management experience required; a minimum of 5 years preferred.

+ Field monitoring experience highly desirable.

+ Ability to build high-performance teams across varied backgrounds and to manage across multinational sites.

+ Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, and preparation of clinical documents in support of regulatory submissions.

Work From Home: Yes

Travel Percentage: Up to 50%

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

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing 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 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 careerconnect 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 and connect
with us on Facebook , LinkedIn and Twitter .

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.
Posted: 2019-07-29 Expires: 2019-08-29

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Senior Manager, Clinical Operations

Kelly Services
Fremont, CA 94536

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