Data Management Supervisor/Manager-00000J06
Description
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To provide leadership of core functions in data management. To review/approve/supervise for key DM technologies, procedures and processes to ensure data accuracy and integrity. To ensure that all activities are conducted in compliance with relevant regulatory requirements.
Core DM job scope included but not limited to:
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Managing and over sighting quality of deliverables for following DM operation activities being conducted by external service providers on (not limited):
1, CRF design and development and eData design/handling; database build/close and logic check set up/UAT; DMP/study convention completion; discrepancy management; SAE reconciliation; PD/IE management.
2, CRF Imaging, ePRO, IXRS and other external data streams transfer specifications, Programming, and Loading; Lab Data Acquisition & Processing; PK/PD Data Acquisition & Processing; Randomization Services; and Electronic Submissions.
3, Quality control in Define.XML and SDTM components.
4, Collaboration with study team members to ensure the database is released according to study objectives. 5, Documentation of all efforts in the cleaning and release of the database.
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Collaborating with DM team leads to ensure operational efficiencies such as resource sharing, staff development, and sharing of best practices across work areas, functions and sites.
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Supporting the head of DM to develop and maintain a support model tracking system and to facilitate issue resolution and capture corrective actions. Providing appropriate metrics generation and reporting.
Qualifications
Qualification and competency requirements：
A. Education /Training background:
Master/ bachelor degree in a scientific discipline or health related field.
B. Knowledge/Skills:
Understanding of relevant regulatory guidelines ICH-GCP.
Good knowledge of drug development process in the pharmaceutical industry
Familiarity with DM systems e.g. Oracle clinical, Medidata Rave, ClinTrial, InForm
Successful completion of multiple trials from beginning to end providing a full scope of Data Management or database manager experiences.
Knowledge of CDISC standards (CDASH & SDTM), SQL & PL/SQL, SAS, C#, Visual Basic, and Define.XML and QC SDTM datasets.
Carrying abilities to work in a multi-disciplinary environment.
Excellent organizational and planning skills in order to meet deadlines and to handle multi tasks.
Strong communication and analytical skills, effectively in a multi-cultural context.
C. Job experience:
5 years (supervisor) or 7 years (manager) above of working experience in clinical data management in pharmaceutical or biotechnology industry.
D. Competency:
Diligent and serious, precise thinking, strong sense of responsibility.
E. Others:
Excellent written and verbal communication skills in Chinese and English.
J2W: LI ASPAC
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical China (7052)
Job Function: Clinical Data Management
Description
-
To provide leadership of core functions in data management. To review/approve/supervise for key DM technologies, procedures and processes to ensure data accuracy and integrity. To ensure that all activities are conducted in compliance with relevant regulatory requirements.
Core DM job scope included but not limited to:
-
Managing and over sighting quality of deliverables for following DM operation activities being conducted by external service providers on (not limited):
1, CRF design and development and eData design/handling; database build/close and logic check set up/UAT; DMP/study convention completion; discrepancy management; SAE reconciliation; PD/IE management.
2, CRF Imaging, ePRO, IXRS and other external data streams transfer specifications, Programming, and Loading; Lab Data Acquisition & Processing; PK/PD Data Acquisition & Processing; Randomization Services; and Electronic Submissions.
3, Quality control in Define.XML and SDTM components.
4, Collaboration with study team members to ensure the database is released according to study objectives. 5, Documentation of all efforts in the cleaning and release of the database.
-
Collaborating with DM team leads to ensure operational efficiencies such as resource sharing, staff development, and sharing of best practices across work areas, functions and sites.
-
Supporting the head of DM to develop and maintain a support model tracking system and to facilitate issue resolution and capture corrective actions. Providing appropriate metrics generation and reporting.
Qualifications
Qualification and competency requirements：
A. Education /Training background:
Master/ bachelor degree in a scientific discipline or health related field.
B. Knowledge/Skills:
Understanding of relevant regulatory guidelines ICH-GCP.
Good knowledge of drug development process in the pharmaceutical industry
Familiarity with DM systems e.g. Oracle clinical, Medidata Rave, ClinTrial, InForm
Successful completion of multiple trials from beginning to end providing a full scope of Data Management or database manager experiences.
Knowledge of CDISC standards (CDASH & SDTM), SQL & PL/SQL, SAS, C#, Visual Basic, and Define.XML and QC SDTM datasets.
Carrying abilities to work in a multi-disciplinary environment.
Excellent organizational and planning skills in order to meet deadlines and to handle multi tasks.
Strong communication and analytical skills, effectively in a multi-cultural context.
C. Job experience:
5 years (supervisor) or 7 years (manager) above of working experience in clinical data management in pharmaceutical or biotechnology industry.
D. Competency:
Diligent and serious, precise thinking, strong sense of responsibility.
E. Others:
Excellent written and verbal communication skills in Chinese and English.
J2W: LI ASPAC
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical China (7052)
Job Function: Clinical Data Management