Direct Hire - Clinical Data Manager job Woodcliff Lake New Jersey
Direct Hire - Clinical Data Manager job Woodcliff Lake New Jersey
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Direct Hire - Clinical Data Manager Job



Employer Name: SpiderID: 7861972
Location: Woodcliff Lake, New Jersey Date Posted: 8/16/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27636

Job Description:

Job Summary



  • Clinical Data Manager, Oncology is responsible for clinical data management activities for studies and ensuring FDA requirements for quality databases submissions are met within this human health care pharmaceutical company.


Responsibilities



  • Perform and manage clinical Data Management (DM) activities for in-house and outsourced trials including protocol review, CRF (Case Report Form) development, database set up activities, data validation process (including manual data review of listings), and SAE (Serious Adverse Events) reconciliation, managing local laboratory and external labs and database lock.

  • Represent DM on clinical teams, coordinate deliverables by other functions and/or CRO (Clinical Research Organization) as necessary to achieve DM deliverables.

  • Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM (Study Data Tabulation Model).

  • Coordinate CRO (Clinical Research Organization) data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution.

  • Perform user acceptance testing of the database using Inform. Design electronic Case Report Forms (eCRFs) for study start-ups.

  • Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed.

  • Responsible for resolving data issues from clinical, SDTM, and Biostatistical groups.


Qualifications
Education



  • Bachelor's degree or above in scientific or related field


Experience



  • 5-7 years' experience in Data Management with experience in managing projects, project teams.

  • Experience with In-Form or other EDC software is desirable. Also, some experience in supporting Oncology studies is a plus.

  • Must be able to work independently and be proficient on all related regulations, GCP, and Good Clinical DM Practice.

  • Knowledge of Standard global medical coding system MedDRA and WHODRUG.

  • Knowledge of the below systems and processes preferred.

  • Clinical Data Management Systems related to EDC studies: Inform, RAVE, COGNOS, and JReview, Clinical Data Management Processes; eCRFs design.

  • Knowledge of CDISC and CDASH preferred.


Skills



  • Project management skills are required

  • Must have strong oral and written communication skills.

  • Leadership skills is a must.




Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 for additional information.

Approx. Duration: Perm

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
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Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.
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