Lead Clinical Data Manager Job

Date: May 3, 2019

Location: Beijing, 11, CN

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Requisition ID: CLI008439

• All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM).
• Accountable for all protocol level start-up, in-life and database lock tasks and activities performed by CDM/SCDM.
• Oversees the technical execution of the CDM/SCDM on achieving customer satisfaction through on-time delivery of quality data at the protocol level.
• Interact and communicate with customers and stakeholders both internal and external to GDMS as well as MSD when needed.
• Responsible to design, create, validate, review, approve and maintain data management tool specifications, 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 the execution of user acceptance testing of data management tools.
• Provide inputs in to the preparation of the investigator meetings materials, and makes him/her available for questions. May need to attend the investigator meeting and present materials based on business need and management decision.
• Participate in relevant operational meetings to ensure global operational issues are identified and incorporated into the study design.
• Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally.
• Execute and ensure adherence to a metrics control plan and quality assessment indicators at the trial level.
• Coordinate the database lock preparation and monitoring of checks, such as data flow and derivations monitoring, for clinical data repository and triage issues according to report output.
• Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.
• Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level, program level, TA level and GDO Level.
• Performs tasks with minimal guidance from manager(s).
• Support and execute any role or task in the team when needed.

Vocabulary Specialist

• Perform vocabulary management activities used to support the medical coding and standardization of clinical trial terminology.

Qualifications

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

Knowledge and Skills:
1. Four years’ experience in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required.
2. Knowledge of database structures and available tools to manage, extract, and report data is preferred.
3. Fluent Oral and written English language skills.
4. Knowledge of applicable regulations and policies.
5. Proficient overall working knowledge of the clinical development process.
6. Good working knowledge of clinical practice and medical terminology.
7. Ability to work cross functionally and as part of a team.
8. Be able to work under pressure in a changing environment with flexibility.
9. Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager.
10. Ability to coordinate the work of others and influence decision making.
11. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
12. Exceptional organizational, problem-solving and negotiating skills.
13. Demonstrated excellent project management and leadership skills.



Job: Clinical Data Management
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Clinic, Database, Medical, Data Management, Pharmacy, Healthcare, Technology, Data

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