Clinical Documentation Specialist Job

CLINICAL DOCUMENT SPECIALIST needed for a contract opportunity with Yoh's client located in Woodcliff Lake, NJ.

WHAT YOU'LL BE DOING:

- Perform daily document management activities such as Review, Processing, Filing of Clinical Trial Master File documents.
- Quality Control review of Regulatory Documents.
- Coordinate with eTMF vendor for TMF set-up and processing of TMF documents.
- Development of user manuals.
- Scanning and storage of Clinical Operation documentation such as CRFs and Trial Master files.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's Degree preferred.
- Two (2) plus years of Pharma experience
- Must have strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines.
- Excellent written, verbal, and interpersonal communication skills.
- Working knowledge of Microsoft Word, Microsoft Excel, Adobe Acrobat, and electronic document management systems, preferably Documentum.
- Agility with ClinOps databases preferred.
- Basic knowledge of CFR, GCP and ICH Guidelines
- Must be able to work independently and possess problem solving skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

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