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Sr. Clinical Project Manager - Direct Hire

Kelly Services

Morrisville, NC
Job Code:
  • Business Development/Operations
  • Healthcare
  • Monitoring
  • Project Management
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Job Details

Job Title Sr. Clinical Project Manager - Direct Hire

Jobid US33YEHS_BH1428216

Location: Morrisville, NC, 27560, USA

Description Kelly Scientific Resources has partnered with a growing company in Austin, Texas and is looking to hire a Sr. Clinical Project Manager.

**Position Summary:**

The CPM (Clinical Project Manager) in close collaboration with their supervisor, is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The CPM, in concert with their supervisor, is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

**Essential Duties and Responsibilities** : To perform this job successfully, an individual must be able to perform the following:

+ Proactively manage project level operational aspects with the Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.
+ Providing efficient updates on trial progress to the Project Team and supervisor(s), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
+ Lead project study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
+ In conjunction with supervisor/mentor, develop, optimize and implement effective project plans for each project
+ Work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
+ Ensure potential study risks are escalated to the attention of supervisor when the probability of occurrence and expected impact suggest a significant risk to timing, cost or quality of the project and where no effective contingency or mitigation strategy has been developed.
**Education/Experience:** The ideal candidate will offer:

+ Minimum of a bachelor degree in Life Sciences or Nursing Licensure
+ Prior experience as a clinical project manager, clinical lead or senior CRA is required.
+ Prior monitoring experience is preferred
+ Relevant therapeutic experience is preferred
**Knowledge, Skills and Abilities:**

+ Demonstrated ability to build a project team environment of open collaboration within a pharmaceutical, biotechnology or CRO organization
+ Demonstrated ability to integrate and mobilize individual team members to achieve project goals
+ Demonstrated ability to understand the relationship between time, cost and quality and to identify which of these is the key driver for project deliverables while balancing the other two
+ Read, write and speak fluent English; excellent verbal and written communication skills
+ Familiarity with MS Project preferred
+ Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and project management methods.
**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 relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda 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 and connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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