Clinical Data Manager

Clinical Data Manager

DMS 420363

COMPANY:

Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.

Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.

LOCATION:

Bridgewater, NJ

DESCRIPTION:

Contribute to data management activities related to drug product development for assigned compounds or indications. Collaborate with internal biostatistics, Clinical Operations, and CRO data management and biostatistics.

Lead efforts for eCRF design with Biostatistics and Clinical Operations and coordinate a final CRF, edit checks, data review and data extracts.

Review published CRFs and hyperlinks in support of FDA, EMEA or worldwide submissions

Review data definition files and other DM or biostatistical components of a submission to ensure content meets Regulatory agency submission requirements

Review CRF for consistency with Company standards

EXPERIENCE:

6-8 years of data management experience with

3 years in a project lead capacity

Must have at least 2 years of Oncology data management experience

Strong project management experience within data management

Proven ability to manage multiple vendors on a given study (i.e., CROs, EDC, Lab vendors)

The ability to interface with Medical Writing, Clinical, Statistics, and Drug Safety

Must attend and/or present at investigator meetings on behalf of company Systems

Excellent communication and writing skills

Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management preferred

Knowledge of EDC and CDISC preferred

EDUCATION:

B.S. required. Preference in science or computers

Please visit

www.discoverysolutions.net

for all of our open positions.

Please refer to job code DMS 420363 when responding to this ad.

Location:	Bridgewater, NJ
County:	Somerset County
ZIP Code:	08807
Pay Rate:	competitive
Job Terms:	full time
Company:	Discovery Solutions, Inc.
Phone:	(443)402-1582
Fax:	410-510-1240