Senior Clinical Data Manager Job

Date: May 3, 2019

Location: Beijing, 11, CN

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Requisition ID: CLI008440






 

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.
  • Supports the LCDM in the
    preparation, creation and review of data management tool specifications and
    tools
  • Participates in 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).
  • Responsible for the
    communication with Clinical Trial Operations team regarding site level issues
    on protocol a basis 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.
  • Complete trial level archiving activities under the
    direction of the LCDM including, but not limited to, filing of essential
    documentation.
  • Coordinate and mentor CDMs and
    other SCDMs who work in his/ her protocol to ensure their 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 be required to support 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.


 

 

Manual
Encoding Lead


  • Perform all responsibilities of a
    Manual Encoder under the Clinical Data Manager.
  • Ensure encoding accuracy and
    consistency across all protocols within a project.
  • Works closely with DMC manual
    encoders and Data Management Trial Manager (DMTM) to ensure all encoding tasks are
    completed prior to interim analysis, frozen files/ database locks.
  • Serves as Subject Matter Expert
    (SME) for encoding documents and processes.
  • Responsible to review specified
    therapeutic area encoding as requested.
  • Coordinates with LCDM to create
    and review encoding specifications documents and performs User Acceptance
    Testing (UAT) of coding application (s).
  • Responsible for encoding external
    partner data as applicable and consultant for Contract Research Organization
    (CRO) partners.
  • Runs encoding check reports in
    accordance with data review plans to identify encoding issues.
  • Raises questions with
    investigational site staff or DMC manual encoders and reviews responses and
    corresponding data corrections to confirm resolution.
  • Responsible for study level encoding
    status
    reporting and assessment, and communication with DMC Clinical Trial (CT)
    management during in-life data management activities and preparation for database lock.


 



Qualifications

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. 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.



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, Technology, Healthcare, Data

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