MSD Senior Clinical Data Manager 

China, Beijing, Huairou District 

182344177

Job Description

Brief Description of Position

• All responsibilities of a Clinical Data Manager.
• Assume data management responsibilities for larger, more complex or higher priority protocols.
• May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS).
• Provide protocol specific training of SDE Process to CDM.
• Triage, research, discuss and resolve the reports outputs provided by Clinical Development Scientist (CDS) and Statisticians at a protocol level during in-life and database lock stages supported by the LCDM. Execute special reports in different systems and coordinate the resolution under direction of the LCDM.
• Responsible for the preparation, creation, validation and review of data management tool specifications and tools under the direction of the LCDM, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
• Coordinate User Acceptance Testing (UAT) of the Clinical Database Repository under the direction of the LCDM.
• Coordinates communications, global status tracking and issue resolution at study level with Lead CDM (LCDM).
• Support LCDM in interaction and communication with customers and stakeholders both internal and external to GDMS as well as company when needed.
• Responsible for the communication with Clinical Trial Operations team regarding site level issues on a protocol on behalf of the LCDM.
• Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to LCDM.
• Responsible for study level status assessment, reporting and communication with LCDM.
• Coordinate and mentor CDMs and other SCDMs who work in his/ her protocol to maintain compliance with SOPs, data management plans and data review plans.

• Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.
• May contribute to special activities such as supporting DMC Process Owner (PO) Models in the local DMC and/or in the Global PO networks.
• Participate in cross functional technical or process improvement projects.

Qualifications, Skills & Experience

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

Knowledge and Skills:

1. Two years’ experience in clinical data management in pharmaceutical or health care clinical research environment is preferable.

2. Self-motivated, excellent in work planning and time management.

3. Fluent oral and written English skills.

4. Good basic awareness of the clinical development process.

5. Good basic awareness of clinical practice and grasp of medical terminology.

6. Good sense and awareness of regulations and policies.

7. Able to work under pressure and in a changing environment with flexibility.

8. Good communication skills with the ability to communicate with both technical and business areas.

9. Proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.