JOB FUNCTION: Data Management
GRADE/TITLE: Senior Manager/Manager
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: China Clinical Development
JOB LOCATION: Beijing, China
REPORTS TO: AD, Data Management
EFFECTIVE DATE: 01-Jul-2019
SUMMARY: Drive the study/project level data management deliverables
DUTIES AND RESPONSIBILITIES:
Plans, executes and completes the study/project related DM activities in studies/projects on time, within budget, and with high quality, consistent with company quality and compliance standards;
Support the set-up and maintains DM outsourcing and oversight model
o Assesses/supports to assess DM vendor contracts including budget estimates;
o Collaborates with internal staff and vendors to monitor data management 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;
Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
Designs and/or reviews eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans, Data Quality Control Plan, detailing complete data management processes throughout clinical studies; Create/Oversee development of data edit check specifications and manual data listings.
Responsible/oversee for data cleaning, query and resolutions, review of medical coding, database lock activities; Responsible/oversee for lab reconciliation, manage and reconcile external data, authoring data transfer agreements, and ensuring study documentation to be filed in the eTMF
Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
Provide support and information to functional areas such as clinical monitoring, medical physicians/medical affairs, and statisticians.
Monitor work productivity or quality to ensure compliance with standard operating procedures.
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.
Education /Training background:
Bachelor, Master or above degree in a scientific discipline or health related field.
Knowledge/Skills: Possesses solid computer system and technical skills with a strong ability to learn multiple e computer applications. Prior experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards are desirable.
o Understanding of relevant regulatory guidelines and GCP
o Understanding of the clinical development process in the pharmaceutical industry
o Familiarity with DM systems e.g. CTMS, Medidata Rave, InForm
o Successful completion of multiple trials from beginning to end providing a full scope of DM experiences
5-8 years or above of working experiences in clinical data management in pharmaceutical or biotechnology industry.
o Diligent and serious, precise thinking, strong sense of responsibility. Operates and executes with limited supervision.
o Good/Excellent written and verbal communication skills in Chinese and English.
Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Reasons when dealing with emotional issues.
Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Communication--Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
Leadership--Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others;Gives appropriate recognition to others.
Ethics--Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Initiative--Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation--Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
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.