1+ months

Clinical Trials Management Associate

Kelly Services
Santa Monica, CA 90407
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Clinical Trials Management Associate** at a prestigious Fortune 500 company working in **Santa Monica.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Clinical Trials Management Associate**

Looking for a seasoned data management consultant with a minimum of 15 years of experience in the biotech or pharma industry.

Looking for someone who can objectively look at existing processes and recommend improvement that are regulation driven and work with many functions to achieve excellence through past experience while focusing on the current and future needs.

Has extensive knowledge and understanding of the business beyond the functional area.

Responsible for directing the implementation of new or advanced systems, processes and tools to increase productivity.

Is a recognized authority in clinical data management area.

Leads data management activities for regulatory submissions.

Drives CDM organizational strategy and implements departmental change.

Solves complex problems directly with minimal guidance (e.g. system down-time, vendor performance issues, legacy trial rescue from acquisitions).

Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.

Ensures clinical data management tasks and corresponding documentation are completed in a manner that is consistent with departmental procedures.

Examines highly complex issues from perspectives as well as determining and applying appropriate clinical data management concepts when addressing clinical data management solutions.

Excellent verbal and written communication skills and interpersonal skills are required.

Capable of recommending new operating procedures as appropriate and determining if clinical data management process needs changes to improve efficiency and minimize errors.

Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required.

Extensive knowledge FDA/EMA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems is also required.

Lead the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.

A minimum of 15 years of data management experience in the pharma / biotech industry.

A BS degree is required, a masters degree is a plus.

Oncology experience is required.

Experience with working in a matrix environment is a must.

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-07-10 Expires: 2020-08-27

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Clinical Trials Management Associate

Kelly Services
Santa Monica, CA 90407

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