Merck
Manager, SDM China Lead
- CHN - Beijing - Beijing (Wangjing Park)
- Full-time
- Posted
Skills
Job description
Job Description
Manage ICSR (Individual Case Safety Report) case management teams or Encoding teams, ensuring operational readiness, quality, and compliance in intake, triage, entry, and analysis of cases, including encoding analysis across sites.
Identify and communicate technology or processes changes affecting case management workflows; coordinate readiness with teams, as needed.
Provide oversight of coding and vocabulary governance, ensuring alignment of terminology standard across programs and platforms; direct cross-functional harmonization initiatives; approve high-impact dictionary or terminology changes impacting multiple therapeutic areas.
Follow documentation, guidelines and regulations updates to maintain proficient data management and coding knowledge.
Showing an increasing capability for technical and process support to direct reports, ensuring they utilize appropriate resources for guidance.
•
Ensure all activities are in compliance with SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization- Good Clinical Practice), GxP and other regulatory requirements, and execution documents.
Monitor and interpret performance metrics to ensure that Compliance, Quality and Productivity goals are met.
Support audit/inspection readiness across multiple functions or regions, and ensure consistent documentation is in place.
•
Provide input on organizational management of SDM (Safety Data Management) resources and processes.
Align on priorities, and close feedback loops to drive high-quality and coordinated delivery.
•
Set clear objectives aligned to organizational goals; assign work and set priorities.
Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring
Demonstrates in adaptability, cultural awareness, and collaboration.
Facilitates communication and alignment with key stakeholders upstream and downstream.
Empowers staff to take ownership and continuously improve outcomes.
High organizational, problem solving, and negotiation skills.
Understanding of the global aspect of SDM sites working as one organization.
Bachelor's degree in Life Science and a minimum of 8 years experience in medical, life-science, or related field, including:
-4 years experience in a biopharmaceutical company
-Deep subject-matter expertise in relevant discipline
OR
•
-3 years experience in a biopharmaceutical company
-People management experience (indirect of matrix leadership)
-Deep subject-matter expertise in relevant discipline
Required Skills:
Adaptability, Adaptability, Audit Readiness, Business Alignment, Career Planning, Clinical Data Management, Clinical Study Protocols, Coaching, Compliance Activities, Data Analysis, Data Processing, Data Review, Data Security, Data Validation, Decision Making, Delivery Management, Enterprise Leadership, Executive Influence, Goal Setting, Good Clinical Data Management Practice (GCDMP), Key Performance Indicators (KPI), Matrix Management, Organizational Leadership, People Leadership, Performance Metrics {+ 10 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
no
Job Posting End Date:
10/31/2026 *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.