Under the direction of the Associate Director/Manager, the External Data Acquisition Operations (EDAO) Analyst II/Senior EDAO analyst is responsible for supporting the portfolio for external data processing setup and in-life activities, in compliance with MSD Standard Operating Procedures (SOPs) and ICH-GCP guidelines. These responsibilities includes responsibility for larger, more complex or higher risk protocols: Working with vendor Qualification teams to perform vendor qualification as an Data transfer SME, working with Study Teams to develop and obtain approval for the data format specifications such as Interchange Format Agreement (IFA) document for each vendor and the Protocol-Specific Addendum (PSA) document for each data type in every study; coordinate/perform User Acceptance Testing (UAT) for Central Vendor studies and ensure production data files are received; external data processing during in-life phase of studies including error remediation and running/reviewing EDAO run evd reports and cumulative compares as established milestones; communication with external vendors and internal cross-functional groups to resolve output from data queries used to perform data quality assessment; and escalation of external data issues with potential impact on the schedule. Primary customers are Global Data Management Services and Clinical Research.
1. At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
2. At least 3 to 5 years’ experience in data management, medical research, or database design and development. Extensive in-life data management experience is required.
3. An overall working knowledge of the clinical development process.
4. Knowledge of database structures and available tools to manage, extract, and report data is preferred.
5. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas and external vendors.
6. Exceptional organizational and problem-solving skills.
7. Ability to establish and maintain good working relationships with different functional areas.
8. Ability to multi-task, work independently under pressure and change environment with flexibility.
9. Strong sense of urgency and customer focus.
10. Desire and ability to learn new processes and technologies
11. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
Job: Clinical Data Management Job Title:Spclst, Clinical Data Mgmt
Primary Location: APAC-CN-11-Chaoyang
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Medical, Pharmacy, Database, Data Management, Healthcare, Research, Technology, Data