DM Project Leader 面议 申请该职位

DM Project Leader

上海

面议 全职| 招聘:1人 | 5-8年| 硕士| 2019-10-28发布

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职位详情

Provides Clinical Research Data Management (DM) leadership and subject matter expertise to the study team(s) and is responsible for overseeing and managing all DM activities for the study and projects.

Serves as a member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation.  This includes, but is not limited to the Data
Management Plan (DMP) and the Data Quality Plan (DQP).

Be responsible for the overall quality and integrity of the
database with respect to “Critical to Quality” (CTQ) data points predefined by
Clinical and Biostatistics prior to the start of a study.

The position holder will project manage the DQP to ensure
CTQ data points are of the highest integrity and completeness.

Role & Responsibility主要职责

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

Operational Responsibilities
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.

Education, Qualifications, Skills and Experience 任职要求

Education: Minimum of a BS in life sciences or computer science degree

Strong Data Management experience in the Biotech/Pharma/CRO industry
Skills/Abilities:

Demonstrated knowledge of clinical and pharmaceutical drug development process

Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities

Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)

State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting

Be familiar with the “End to End” concept from protocol development to CSR generation

Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)

Demonstrated understanding of clinical data system design / development / validation and system interoperability.

Demonstrated leadership (including in an outsourced environment)
Excellent understanding and demonstration of the DZ values and behaviours

Demonstrated project management skills

Strong communication and interpersonal skills

Excellent organizational and analytical skills

Ability to work independently

Demonstrated ability to work effectively with external partners

Ability to negotiate and influence others across functional areas

Excellent written and verbal communication skills

Effective problem and conflict solving skills

Ability to work in a global team environment

Ability to interact effectively with all levels of management

High attention to detail and accuracy

工作地点

上海浦东新区张江镇亮景路199号 查看地图

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