CTG SENIOR LEAD DATA MANAGER in Whippany, New Jersey
Title: SENIOR LEAD DATA MANAGER
Job Number: 18202387
CTG is seeking a Senior Lead Data Manager (LDM) to work at their clients site in Whippany, NJ. This is a 9 month contract position with the potential to extend longer.
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.
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, she/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 Bayer 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.
Preferences/Nice to Have:
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.)
This position is compensated per hour on a W2 hourly basis (no C2C or 1099's).
Apply below or send your resume to Holly Wilson at email@example.com. Please reference job 1822387/B-2293 in the subject line.
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 (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
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 in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace 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: Data Analysis / Management