Kelly Services, Inc.
Senior Clinical Trial Manager
San Francisco, CA, 94103, USA
**_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
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 kellyservices.com 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.
Kelly Services, Inc.
Website : http://www.kellyservices.com
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.