Senior Clinical Data Manager I

4 weeks ago

Beijing, China MSD Full time

Job Description

Brief Description of Position

Position Overview:

Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Primary activities include, but are not limited to:

  • 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

Education:

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 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID:R284619

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