Requisition ID: CLI007895
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company : one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Position Overview:
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.
Responsibilities includes, but not limited to:
:Responsibility for larger, more complex or higher risk protocols: Working with Vendor Qualification teams to perform Vendor Qualification as a Data Transfer SME;
:Working with Study Teams to develop and obtain approval for the data format specifications such as Data Transfer Specifications (DTS) document for each vendor and data type;
:Coordinate/perform User Acceptance Testing (UAT) as needed for central vendors and ensure production data files are received/loaded successfully in our database;
:External data processing during in:life phase of studies, including but not limited to SQLs running/reviewing outputs as established milestones;
:Communication with external vendors and internal cross:functional groups to resolve output from data queries used to perform data quality assessment;
:Escalation of external data issues with potential impact on the schedule.
Primary customers are Global Data Management Services and Clinical Research.
Primary activities:
Assumes the responsibilities for all external data related activities including external data set up with vendor and internally to support multiple clinical programs. Coordinates and participates in the following activities:
:Create, review and get appropriate approval on external data format specifications documents such as Data Transfer Specifications (DTS) with new vendors and / or with existing vendors / new data types and Test Codes Mapping Spreadsheets for each vendor / data type.
:Perform testing based on set up documents which includes coordinating with vendors and Clinical Data Testing group.
:Run and review SQLs output reports. All vendors' related issues will be communicated back to vendors until resolved, as applicable.
:Support Vendor Qualifications as a Data Transfer SME.
:Participate in process improvement initiatives, departmental meetings, and special projects, mentor and train team members as applicable.
Qualifications
Requirements:
Education: At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Biochemistry, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
:Advanced English level (oral and written)
:At least 1 or 2 years' experience in data management, medical research, or database design and development desirable.
:An overall working knowledge of the clinical development process.
:Knowledge of database structures and available tools to manage, extract, and report data is preferred.
: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 change environment with flexibility.
:Strong sense of urgency and customer focus.
:Desire and ability to learn new processes and technologies.
Our employees are the key to our company's success. We dem
