Edao Analyst

**Job Description**:
**Reporting directly to Head/Manager of eClinical Technologies, the EDAO Analyst** will create, review, and facilitate approval of external data format specification documents including, but not limited to; Data Transfer Specifications (DTS) & Electronic Data Transfer (eDT).

Coordinate with external vendors, Information Technology (IT), and the other supporting functions to validate external data transfers into Merck’s data management system in accordance with detailed transfer specifications.

During the in-life portion of a study, and in preparation for interim and end-of-study database locks, execute and review output of assigned reports to ensure completeness of data transfers; communicate and resolve external data loading issues with vendors and IT, as appropriate.

Contribute to, and ensure consistency with, data management standards and specifications for external data.

Leads vendor management and relationship activities.

Assists Program Managers as primary Subject Matter Experts as appropriate.

Trains and mentors new or junior EDAO analysts, as appropriate.

Participate or lead in process improvement initiatives, departmental meetings, and special projects as assigned.

Supports audits and inspections as necessary.

**Education**:
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological or Computer Sciences, or health care related discipline.

**Knowledge and Skills**:
At least 3 to 5 years’ experience in data management, medical research, or database design and development. In-life data management experience is required. An overall working knowledge of the clinical development process. Knowledge of database structures and available tools to manage, extract, and report data is preferred. Knowledge of a Library Standards process and experience working with CDISC Standards (SDTM, CDASH, Controlled Vocabularies); Preferably at least 1 year experience following CDISC Standards. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas and external vendors. Exceptional organizational and problem-solving skills. Ability to establish and maintain good working relationships with different functional areas. Ability to multi-task, work independently under pressure, and adapt to changing environments. Strong sense of urgency and customer focus. Desire and ability to learn new processes and technologies. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R206104