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Clinical Trials Manager - I

Ascent Foster City Contractor
$50.00 - $85.00 / hour
Apply Now
19-09101 / Clinical Trials Manager I
Location: Foster City, CA
Industry: Biotechnology / Pharma
Position Type: Initial 6-Month Contract (w2 employee- no c2c) Possibility to extend
 
Those who submit a cover letter will be viewed first! 

No Travel
No OT
Open to non-local candidates, but must relocate at their own expense.
Must be Flexible and work with the different functional areas and teams.
 
Job Duties:
  • Provide guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
  • May design and use all available vehicles for scientific communication within company. With limited supervision may participate in or lead departmental strategic initiatives
  • Contributes to the development of presentations
  • Partner with functional peers to manage, adjust, and revise project timelines/budgets as necessary
  • Communicate project status and issues and ensure project team goals are met
  • Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals
  • Ability to examine functional issues from a broader organizational perspective
  • Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision
  • Must be able to resolve problems using national and international regulations, guidelines and investigator interaction
Qualification/Education:
  • Education: Bachelors is a must!
  • Years of Experience: 2-3 years of related experience 
  • Ability to write study protocols, study reports, sections for investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision
  • Thorough knowledge and understanding of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials
  • Experience in developing RFPs and selection and management of CROs/vendors
  • Functional expertise to initiate, author, or contribute to SOP development, implementation and training
  • Excellent interpersonal skills and demonstrated ability to lead is required

*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 


 

Recommended skills

Timelines
Presentations
Non Disclosure Agreement (Intellectual Property Law)
Request For Proposal
Ich Guidelines
Clinical Trials
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Job ID: 19-09101

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The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. ASG works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. ASG was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.

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