Department Data

Management

Responsibilities

1. Responsible for ensuring the completeness, quality, and integrity of the Clinical Trial data.

2. Ensure data quality and consistency according to applicable regulatory requirements, standard operating procedures (SOPs), processes and data standards.

3. Ensure all data management activities to be compliance with GCP, relevant regulatory requirements, and SOP/WI (work instructions) of Pharmaron Clinical and/or Sponsor.

4. Ensure acknowledge, follow and to be consistent with Pharmaron Clinical policies and procedures.

5. Act as Lead Data Manager for multiple ongoing clinical studies.

6. Ability to train junior Clinical Data Managers and assign tasks as required.

7. Ability to create, and maintain DM Timelines. 8. Responsible for leading team activities with the sponsor.

9. Responsible for creating and maintaining the Global Library.

10. Responsible for maintaining eTMF and TMF (where applicable).

11. Hands-on data management responsibilities but not limited to:

• CRF collections, maintenance, and tracking.

• User acceptance testing (UAT) for database.

• Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and manual review (review of data listings to verify quality and completeness of data).

• Create the relevant documentations/files, e.g., Case Report Forms, Data Management Plan, Edit Check Specification, Data Review Plan, UAT Plan, Data Transfer Specification, and CRF Completion Guidelines, etc.

• Run ancillary reports as necessary.

• Experience with database setup and database lock activities.

• Participate internal/external functional meetings as required.

• Peer Review Study documents as required.

• Serve as client contact for project meetings and DM status updates.

• Interact and collaborate with other project and cross-functional team members including clinical, programming, statistics, database manager, medical coder, etc.

• Train end users on data collection tools.

Qualification

• 7+ years of experience in the Data Management field, experience of managing CROs and Data Management vendors is required, working in a global/cross cultural setting is preferred.

• Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation.

• Advanced knowledge of clinical database design is a must. RAVE experience preferred.

• Knowledge of FDA/ICH guidelines and industry standard practices regarding programming.

• Knowledge of SQL and SAS programming.

• Excellent oral and written communication skills in English.

• Strong problem-solving and time management skills.

• Team lead experience and ability to manage groups of data managers to ensure timely completion of clinical studies.

• High degree of enthusiasm and a strong sense of responsibility.

• Adapt to work with highly-accurate, high attention of details, and strict quality control.

• Ability to work in cross-functional team setting as well as independently.

• Ability to multitask and balance several ongoing projects.

'• Oncology Study experiences are a plus.