Kelly Services Clinical Data Manager in Raritan, New Jersey
Contract Clinical Data Manager – Raritan, NJ
Under supervision of the Manager of Data Management, plans and executes clinical database activities of varying complexity in support of FDA 510k, PMA and BLA submissions, and international registrations.
This is a 1 year contract position with Kelly OCG (Outsource Consulting Group). You will receive full benefits including Medical, Dental, Vision, Paid vacation, Holidays, sick time,, 401k, etc.
Coordinate and ensure the timely completion of all Data Management activities for assigned projects following appropriate regulatory guidelines, and company and department SOPs.
Provide technical and Data Management expertise as a member of a cross-functional project team.
Write clinical Data Management Plans and associated documents i.e., database specifications, data entry guidelines and drive the project team review and approval process.
Facilitate clinical trial eCRF development or other data capture processes.
Oversee and/or conduct and document the User Acceptance Testing of data entry screens, database build and edit check programming.
Process and manage instrument generated data including edit checks using SAS.
Perform data review activities and interact with clinical sites or the responsible CRA to coordinate error resolution using Data Clarification Forms and deviation documents. Special projects as assigned.
A higher degree Bachelor s degree, etc. in a computer science/technical/scientific field with a minimum of 5 years of Clinical Data Management experience is required.
Training in GCP, GMP and pertinent sections of FDA Code of Federal Regulations e.g. CFR 21 part 11 is required. Knowledge of SAS is Preferred.
Familiarity with clinical trial protocols, analysis plans, analysis requirements documents, company and departmental SOP s required.
Knowledge and demonstrated skills using PageMaker or InDesign is highly desired.
Knowledge of Medadata is required.
Project management skills as evidenced by the ability to function as a member of a cross-functional project team is preferred. Knowledge of maintenance Trial Master File TMF and Site Regulatory file.
Collects, verifies acceptability and distributes all Investigative site regulatory documentation to Regulatory Affairs as appropriate.
Prior experience in the diagnostics industry is preferred.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "apply now" button below to submit your resumes. Resumes in MS Word are preferred. If you have questions about the position, you may contact the recruiter at Leslie.Hesano@kellyservices.com ; however your resume must be received via the "apply now" button included within.
Why Kelly ® ?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm