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Senior Clinical Trial Manager

Kelly Services

San Francisco, CA
Job Code:
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Job Details

Job Title Senior Clinical Trial Manager

Jobid US24R4LR_BH1436633

Location: San Francisco, CA, 94103, USA

Description **_Senior Clinical Trial Manager, San Francisco, CA_**

Kelly Services is currently seeking a **_Senior Clinical Trial Manager_** _for_ one of our top clients in San Francisco, CA.

**Projected Duration** : 05/01/2018 – 10/27/2018

**Type** : Contract

**Pay:** Up to $74/hr

**Specific requirements and skill level details need to be met if not exceeded to be considered**

**Job Requirements:**

+ A Bachelor’s degree or equivalent is required (life science degree is preferred).
+ An average of 8-10 years in the pharmaceutical industry is required, including but not limited to 4 years overseeing trial management.

+ Must have demonstrated problem solving abilities and strong organizational skills.
+ Excellent written and verbal communication skills are required. Strong computer skills (MS Office) are required.
+ Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required.
+ Must be a demonstrated self-starter and team player with strong interpersonal skills.
+ Must possess excellent cross-functional clinical project management skills.
+ Demonstrated ability to develop and implement SOPs and Study Plans.
+ Strong experience working as a Clinical Research Associate is preferred and thorough knowledge of clinical monitoring practices is required.

+ The Senior Clinical Trial Manager will manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high risk.
+ The Senior Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Client’s SOPs.
+ Oversee and manage all aspects of a clinical trial in accordance with Client’s SOPs, ICH/GCP regulations and study-specific manuals and procedures.
+ Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable.
+ Develop and manage effective relationships with key study stakeholders.
+ Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.).
+ Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management.
+ Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately.
+ In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary.
+ Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents.
+ Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock.
+ Project and coordinate study supply and packaging requirements.
+ Identify program/resource gaps and proposes solutions.
+ Provide weekly enrollment and program updates to senior management.
+ Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations.
**Lauren Rogers, Kelly Services Scientific Recruiter**

**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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