DMPL

A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking a DMPL to join their office in Shanghai. The organisation, which is a subsidiary of an international pharmaceutical corporation, specialises in increasing China's core competitive power in the innovation of new drugs. This is an exciting opportunity to work with a prestigious company that develops first-class drugs.

Job Responsibilities:

• Serves as the expert in Clinical Research Data Management (DM) to provide oversight and advice to the clinical study team(s) regarding the DM activities and deliverables
• Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization
• Provides input to the DM related activities associated with regulatory inspections/audits
• Provide DM business expertise and consultancy in the selection and use of software systems and vendors
• Contribute to DM processes and standards
• Ensure the quality and consistency with company strategies and standards across therapeutic areas
• Provide input into collection standards and processes based on industry best practices
• May be asked to provide strategic DM expertise to company Clinical Initiatives
• Management and oversight of vendor contracts, resourcing and budgets
• Reviews, assesses and manages DM delivery against KPIs and overall DM performance
• Provides input into the contract process for the Data Management
• Manages all Data Management timelines and DM Deliverables for assigned studies
• Accountable for the execution and overall quality of DM activities and deliverables.
• Acts as the single point of contact for all data management for the study team during the study set-up phase, accountable for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.
• Provide guidance and supervision to Lead Data Managers working on the study (CRO or in-house) and coordinate the data analysis team for on-time deliverables.
• Accountable for "Real Time Data Management" (RTDM), ensuring that DM conducts initial reviews within 5 days (or agreed timeline) of a patient's data entering the EDC system, and manages the average query aging to no more than 20 days (or agreed timeline).
• Accountable for the overall quality and completeness of the Data Management Plan (DMP) and the Data Quality Plan (DQP).
• Provide input on functional excellence activities.

Skills and Requirements:

• A university degree in a relevant subject, and demonstrable experience in a similar or comparable field.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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