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Clinical Data Standards Expert

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POST DATE 8/24/2016
END DATE 10/18/2016

Chiltern Trenton, NJ

Company
Chiltern
Job Classification
Full Time
Company Ref #
1299
AJE Ref #
575970076
Location
Trenton, NJ
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
CLINICAL DATA STANDARDS EXPERT

JOB REFERENCE

1299

JOB BACKGROUND

Come join a leading player in the discovery of new molecules in both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. This is an In House position with a growing pharmaceutical company located in Mahwah, NJ.

The Clinical Data Standards Expert will provide experienced standard and regulatory compliant insight to Clinical Development Plans (CDP), Clinical Study Protocols (CSP) and Clinical Study Reports (CSR) across the Innovative and Approved products/Branded generic portfolio globally. The candidate should be able to think with the end of mind to ensure the compliance in terms of data collection and presentation to support regulatory dossier submission.

DUTIES & RESPONSIBILITIES

1. Accountable for ensuring that submission datasets are conforming to the data standards required by regulatory agencies.

2. Lead the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs, ) to produce compliant datasets for regulatory submission.

3. Maintain knowledge of regulatory developments related to data standardization, follow the latest submissions requirements of the agencies.

4. Participate in standards-related process improvement meetings/workshops.

REQUIREMENTS

Minimum MSc level.

Technical competence: CDASH, SDTM, Define.sml, DCISC controlled terminology.

Experience with preparing, reviewing and submitting CDISC-compliant datasets to the regulatory agencies (i.e. FDA).

Experience overseeing contractor/CRO activities.

Experience in standardization of clinical collections and submission modules.

Experience and knowledge in clinical data management tools is desirable.

External recognition desirable (i.e. CDISC team member).

Technical experience in programming tools is desirable

Project management experience

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

SALARY

DOE

POSITION TYPE

Permanent
Full Time

CONTACT

Email Wanda Craddock
434.409.8555