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Study Data Manager II

Job Description

20-03964 / Study Data Manager II
Location: South San Francisco, CA (100% onsite role once SAH order is lifted)
Industry: Biotechnology / Pharma
Type: Initial 1-year contract with chance to grow career
Level: 4+ years of Clinical Data Management Experience
 
Bay Area residents, who submit a cover letter will be viewed first!
 An excellent opportunity to get your foot in the door with one of the leading Biotech companies in the world!
 
Summary of This Opportunity:
  • Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.
  • Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met.
Duties:
  • Provides early strategic input into protocol design focused on data management issues
  • Leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives
  • Responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals
  • Responsible for the implementation of standards within Study Data Management across one or more CDM study teams
  • Develops and executes ad hoc database queries utilizing data review and query tools
  • Manages projects resourced externally via contract research organizations (CROs) or corporate partners.
  • Ability to apply advanced principles, theories and concepts for CDM team as a whole.
Must Haves:
  • B.A./B.S. Degree or equivalent and around 5 years’ experience in Clinical Data Management
  • Clinical data management system experience (EDC Medidata Rave strongly preferred).
  • Knowledge of core clinical data management applications:
    • Clinical data management systems
    • Electronic data capture
    • Query tools
  • Understanding of the conceptual basis for data management conventions, standards and processes.
  • Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.
Soft Skills:
  • Ability to develop solutions to complex problems.
  • Ability to multi-task and effectively set own priorities.
  • Strong organizational skills.
  • Strong communication and interpersonal skills.
 
*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*

Job Requirements

 

Job Snapshot

Location US-CA-South San Francisco
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific, Energy, Oil & Gas, Other
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Company Overview

Ascent

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. Learn More

Contact Information

US-CA-South San Francisco
Bonnie Galley
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Snapshot
Ascent
Company:
US-CA-South San Francisco
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific, Energy, Oil & Gas, Other
Store Type:

Job Description

20-03964 / Study Data Manager II
Location: South San Francisco, CA (100% onsite role once SAH order is lifted)
Industry: Biotechnology / Pharma
Type: Initial 1-year contract with chance to grow career
Level: 4+ years of Clinical Data Management Experience
 
Bay Area residents, who submit a cover letter will be viewed first!
 An excellent opportunity to get your foot in the door with one of the leading Biotech companies in the world!
 
Summary of This Opportunity:
  • Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.
  • Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met.
Duties:
  • Provides early strategic input into protocol design focused on data management issues
  • Leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives
  • Responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals
  • Responsible for the implementation of standards within Study Data Management across one or more CDM study teams
  • Develops and executes ad hoc database queries utilizing data review and query tools
  • Manages projects resourced externally via contract research organizations (CROs) or corporate partners.
  • Ability to apply advanced principles, theories and concepts for CDM team as a whole.
Must Haves:
  • B.A./B.S. Degree or equivalent and around 5 years’ experience in Clinical Data Management
  • Clinical data management system experience (EDC Medidata Rave strongly preferred).
  • Knowledge of core clinical data management applications:
    • Clinical data management systems
    • Electronic data capture
    • Query tools
  • Understanding of the conceptual basis for data management conventions, standards and processes.
  • Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.
Soft Skills:
  • Ability to develop solutions to complex problems.
  • Ability to multi-task and effectively set own priorities.
  • Strong organizational skills.
  • Strong communication and interpersonal skills.
 
*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*

Job Requirements

 
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Study Data Manager II Apply now