JOB FUNCTION: Data Management
GRADE/TITLE: Level 10/Senior Director
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: China Clinical Development
JOB LOCATION: Beijing, China
REPORTS TO: CMO (or future Head of Biometrics)
EFFECTIVE DATE: 3/29/2019 or earlier
SUMMARY: Drive the Data Management strategy and deliverables
DUTIES AND RESPONSIBILITIES:
Drives Data Management (DM) strategy and deliverables, process optimization and innovation;
Establishes DM-related internal processes, policies, procedures, training and quality standards;
Plans, executes and completes all DM activities on time, within budget, and with high quality, consistent with company quality and compliance standards;
Sets up and maintains DM outsourcing and oversight model
Assesses DM vendor contracts including budget estimates;
Collaborates with internal staff and vendors to monitor work and ensures delivery of milestones to include data capturing form and specifications, data display, data cleaning, database lock, and data reporting that meet pre-defined expectations and regulatory requirements;
Collaborates with business partners on DM-related deliverables for co-development programs;
Manages risks: responsible for anticipation, prevention and early detection of issues impacting DM deliverables. Coordinates real time inspection readiness for all DM deliverables as necessary.
Master or above degree in a scientific discipline or healthcare-related field.
Good understanding of relevant regulatory guidelines and GCP and clinical development process in the pharmaceutical industry.
Knowledge of different DM systems e.g. CTMS, Medidata Rave, ClinTrial, InForm
Successful completion of multiple trials from beginning to end providing a full scope of DM experience.
10+ years or above of working experiences in clinical DM in pharma or Biotech.
Excellent written and verbal communication skills in Chinese and English. Ability to explain DM requirements to team members in a simple & effective fashion.
Good people leadership skills and people management experience is preferred.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.