**5520BR**

**Title:**

Manager, Clinical Data Management

**Job Description:**

**Job Summary:**

The Data Manager will work closely with the Clinical Project Managers to oversee data management activities performed by the designated EDC vendor and core lab(s) with the purpose to deliver a clean and complete database for statistical analysis.

**Job Details:**

1. Develops Data Management Plan (DMP), maintains DMP throughoutlifecycle of study project and ensures DMP is followed according to IDE study design and methodologies

2. Reviews and provides input to IDE study protocol, Statistical Analysis Plan (SAP), and other documents collaborating with statistician

3. Develops Case Report Form (CRF), electronic and/or paper and its implementation with study teams and eDC vendor(s)

4. Collaborates with external CRO for database programming to establish timely delivery of the clinical database setup, including creation and testing of edit checks; trouble-shoots to identify issues

5. Develops database (DB) clinical trial data specifications, including eCRFdesign, user requirements, edit rules/checks, query logic and datavalidations

6. Leads EDC database (DB) specification process

7. Develops Data Transfer Agreement(s) (DTAs) between external datavendors and/or core labs

8. Advises Study Team on Data Management related aspects, seeks clarification on specific study needs, provides status/progress updates and highlights issues found during CRF review

9. Participates in data review meetings and Clinical Event Adjudication meetings to discuss specific data values relevant for the analysis/determining subject populations

10. Maintains Data Validation Specifications (for computerized and manual checks), including testing computerized edit checks and ensures they are reviewed by the relevant stakeholders

11. Acts as liaison for internal colleagues, as well as involved CRO and other vendors to agree upon data management related timelines

12. Ensures specifications for the electronic data (i.e., angiography, ultrasounds, etc.) are created and provided to external vendor; in case of local hospital labs, ensures laboratory ranges and units are collected

13. Performs, oversees, completes and provides accurate review and processing of clinical trial data, including identification, resolution and clarification of any missing, inconsistent or clinically questionable data by the study team and/or sites

14. Participates in reconciliation of Serious Adverse Events between Clinical and Clinical Event adjudication databases

15. Generates data management study status/progress overviews or ensures these overviews are created

16. Reviews data management study status/progress overviews and takes appropriate action

17. Participates in CRO evaluation to ensure organization is in alignment across all Clinical Programs

18. Performs other duties and responsibilities as assigned

**Auto req ID:**

5520BR

**City:**

Somerset

**Qualifications:**

**Position Requirements:**

**Knowledge, Skills and Abilities (KSAs)**

1. Demonstrated knowledge of medical terminology

2. Demonstrated knowledge of personal computers, database structures and database management software

3. Adept at problem solving, numerical abilities and analytical skills

4. Excellent planning and organizational skills; ability to prioritize work

5. Good project management and coordination skills

6. Experience in working with electronic data capture tools

7. Experience in working with CROs/EDC vendors for data management activities is desirable

8. Excellent written and verbal communication skills

9. Proficient with MS Word, Excel and Outlook

**Background Experience**

1. BS/BA Degree in a biological science, health-related, or Computer Science field

2. A minimum of two years of experience as a Data Manager

3. A combination of data management experience and college courses in a related field may be considered

4. Four to six years of related experience in medical device and/or pharmaceutical clinical research or health services industry

5. Ability to interface directly with the EDC vendor to oversee study database development

**Location:**

Somerset Davidson

**State:**

New Jersey

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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