- Entry level
- No Education
- Salary to negotiate
You will be responsible for:
Performing data management activities for both clinical studies and development projects as assigned. Ensuring the delivery of complete, accurate data that is ready for analysis and regulatory submission.
Defining and applying study-specific data management workflow. Interacting with internal and external teams to define study-specific data requirements.
Participating in database planning and user acceptance testing. Organizing and facilitating data entry and data management tasks to ensure timely study deliverables. May having primary ownership of one or more projects.
Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for clinical data management issues for assigned components.
Using knowledge of clinical data management to define data flow for assigned projects. Identifying and implementing updates to study-specific processes as needed.
Creating or oversees creation of data management documentation for assigned projects, including the Case Report Form (CRF), Data Management Plan (DMP), and clinical database specifications. Maintains robust documentation to ensure and/or document regulatory compliance at all times. Identifies and implements updates to documentation as needed.
Using knowledge of database management to define clinical database requirements. Performs user acceptance testing of clinical database and edit checks.
Provides study-specific data entry training to data entry staff. Oversees data entry staff to ensure data quality.
Performs clinical study data review as required by the DMP. Identifies incomplete, erroneous, and/or discrepant data and uses discretion to resolve issues. Identifies and manages data trends.
Managing data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team. Using professional judgment to escalate issues appropriately.
Updating clinical database based on queries, data clarification forms, discrepancy management guidelines, and performing other database changes as necessary for a study.
Maintaining proficiency in use and analysis of clinical database system(s) and overall awareness of clinical data management practices.
Developing local data management related SOPs according to the requests of Dia Symphony, Divisional Standard, Guideline and GCP；
Being window person of MRA data management to other functions, handling inquiring and feedback; providing active and strong technical supports to internal or external as needed. keeping smoothly interaction with global DM team.
Developing and maintaining a good working relationship with other functions, to support the clinical projects.
Conducting business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection
Performs other duties as assigned.
You should have:
At least Bachelor degree in medical science degree, preferably in preventive medicine, medical laboratory, pharmacology, biological sciences, or health care related discipline.
Familiarity with regulatory and ICH-GCP guidelines applicable to data management.
Proficiency in both spoken and written English.
Good command of MS office software application. Ability to work with relevant computer software, including spreadsheets, word-processing and database packages (e.g., Microsoft Excel, Word and Access).
Ability to work with clinical database software (e.g., Medrio, Oracle Clinical, RAVE, Inform, etc.).
Ability to work under time pressure while maintaining high standards of precision and data quality.
Ability to prioritize multiple projects.
Comprehensive understanding of the clinical study process.
Excellent communication and interpersonal skills.
At least 3 years of clinical data management experience with Global pharmaceutical companies, Medical Device companies, Clinical Research Organization, Business Process Outsourcing companies.
Clinical database setting up SAS programming and data management procedure development experience is preferred.
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.