Senior Lead Data Manager

New
  • Location
    Whippany, New Jersey
  • Job type
    Contract/Temporary
  • Category
    Information Technology - Database Administrator

Adecco is currently assisting a local client in their search to fill an exciting Senior Lead Data Manager in Whippany, New Jersey! Apply now if you meet the qualifications listed below!


DEPARTMENT/TEAM DESCRIPTION
Oncology Business Unit – Medical & Data Management. Data management serves as key subject matter expert on topics related to data management activities. Contributions
include, but are not limited: vendor selection and management, mentoring junior staff, training team members, ongoing data review and reconciliation, project data management.

POSITION SUMMARY
The Senior Lead Data Manager (Sr. LDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The Sr. LDM may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Oncology Data Management on the Core Study Team.

POSITION DUTIES & RESPONSIBILITIES

The Sr. Lead DM assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and applies Data Management best practices
Incorporates and maintains our standards in clinical studies and projects for all elements of the medical standards package
Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the SDMD, maintaining document management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC, etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled
Specifies and develops study specific eCRFs, database structures and data consistency checks based on medical standards, the Clinical Study Protocol and input from the study team
Prepares, tracks and implements standard plans (i.e., GDM Study Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities
Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final Validity Review Meeting
Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions
Identifies and issues queries, incorporates query replies, tracks query status


Education Requirement

Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation


Requirements

At least 5 years of study and/or project level experience as a Data Manager in supportive and leading roles
At least 2 years of experience should demonstrate responsibility as a study leader
Good understanding of the drug development process
Strong organizational skills and able to collaborate with minimal supervision


Preferences

Basic SAS Programming knowledge or other database experience
Significant experience in using data management methodologies and technologies (e.g. data warehousing, electronic data capture)
Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA], etc.)


Role: Contract
Title: Senior Lead Data Manager
Location: Whippany, New Jersey 07981
Pay: negotiable based on experience
Start: 5/04/2018
Shift: M-F 8am-5pm
Duration: 12 months
Travel Requirements: none


How to Apply: Click on “Apply Now” to be considered for this position or any other opportunities with Adecco.

IMPORTANT: This position is being recruited for by Adecco’s National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the “apply now” button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above. For other opportunities available at Adecco go to www.adeccousa.com.

If you have any questions surrounding the application process, please feel free to reach out to: Lisbeth Vences at lisbeth.vences@adeccona.com. You can also email your most current resume in word format to the email listed.

The Adecco Group is a global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Group provides one of the most comprehensive benefits packages in the industry to contract workers to include Holiday, 401(k), Insurance Benefit Plans and Service/Anniversary Bonus opportunities.

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Reference number US_EN_2_022862_403563