Salary

$45 - $49 Per Hour

Job Type

Contractor

posted

8 days ago

Location

Raritan, NJ

Description

JOB DESCRIPTION:
Under supervision of the Manager of Data Management, plans and executes clinical data management and database activities of varying complexity in support of FDA 510k, PMA and BLA submissions, and International registrations.

Core Responsibilities:
• 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.

Qualifications:
• Bachelor's degree or higher 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.
• Experience in SAS programming is preferred.
• Experience in Medidata RAVE is required. Ability to conduct study builds and program edit checks preferred.
• Familiarity with Clinical Trial protocols and analysis requirements documents is required.
• Must be able to work both independently and within a cross-functional team environment.
• Proven oral and written communication skills.

Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.

About the Company

Company Logo Nesco Resource, LLC
Company Logo Nesco Resource, LLC
Company Logo Nesco Resource, LLC
Company Logo Nesco Resource, LLC

Nesco Resource, LLC

Companies need talent. You want job opportunities.

That’s where we come in. We create meaningful connections between companies and candidates, and we’ve been doing it for over 65 years.
Our national workforce solutions include contract, contract-to-hire, direct placement services, and managed services for a variety of industries.

We employ specialized recruiters focused in Engineering, Information Technology, Accounting & Finance, Administrative & Customer Service, and Manufacturing & Distribution.

When you need to find a job, we're your partner.

Company Size

10,000 employees or more

Industry

Staffing/Employment Agencies

Employee Benefits

Employee Referral Program, Paid Holidays, Paid sick days, Parking , Performance bonus, Vacation/paid time off

Founded

1956

Website

https://nescoresource.com/