CTG Senior Lead Data Managers in Whippany, New Jersey
Title: Senior Lead Data Managers
Job Number: 17202974
CTG's premier global client in Whippany, NJ, has 12 month assignments for Senior Lead Data Managers! The Senior Lead Data Manager 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. 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.
Major responsibilities of this position are:
Incorporates and maintains client 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
Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation
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
Basic SAS Programming knowledge, or other database experience, preferred
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.)
This position pays on a W2 hourly basis (no C2C or 1099's).
APPLY NOW for resume review by recruiter Pam Gewin!
IMPORTANT NOTE: All qualified candidates must successfully pass a background check and a drug screen to be considered for the position.
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG is the most reliable IT services provider, built on 50 years of meeting our commitments to make technology work for clients and deliver real business value. CTG provides industry-specific IT strategy, services, and solutions that address the business needs and staffing challenges of clients in high-growth industries, including major technology companies, large corporations, and government entities located in North America and Western Europe.
CTG's greatest asset is its people, and as such we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work Company by Modern Healthcare (since 2013) in North America, and a Best Places to Work Company in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Project Management & Administration