This position will be responsible for managing activities associated with the Data Management process throughout the lifecycle of an interventional or non-interventional study and overall quality and integrity of data input and output. This position reports to the Director of Real World Study Strategic Planning in Medical Affairs.

Responsibilities：

We are looking for experienced candidates for the position of clinical data manager.

1. Accountable for the end-to-end Data Management activities of (multiple) assigned clinical studies to ensure consistency of clinical data standards across studies with minimal guidance

 Electronic Case Report Form and (electronic) Diary Cards/patient-reported outcomes (PRO) data & other clinical outcome assessments

 Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation

 Electronic Data Capture (EDC) platforms set up, incl. safety package, severe adverse event (SAE)/adverse event (AE) reconciliation

 Interim and final cleaned database lock

 Archival of all Data Management documents in the electronic Trial Master File (eTMF)

 Archival of the study database and provision of clinical data to the study site

 Other Data Management activities as needed

2. For outsourced studies, manage and monitor the design and implementation of clinical Data Management processes with CROs or other vendors on assigned studies, and ensure completeness, accuracy, consistency and integrity of data and data structure across studies and drive timely data lock.

3. Provides Data Management inputs into the study design, study planning, and study documents, such as protocol, Clinical Monitoring Plans (CMPs), Statistical Analysis Plans (SAPs) and vendor specifications

4. Provide Data Management input in vendor specifications, preparation of Request for Proposal (RFP) and Scope of Work (SoW)

5. Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel

6. Represent Data Management at investigator meetings and may present EDC and case report forms to investigators

7. Provides reports, status updates, feedback and advice related Data Management activities to key study stakeholders on study progress

8. Creates or reviews study level timelines for Data Management deliverables

9. Provides input to the development of budgets forecasts for studies in planning

Qualifications：

 Master's degree in health or science related disciplines, such as epidemiology, biostatistics/statistics, data science, computer science, etc.

 3-5 years of experience in managing Data Management activities in pharmaceutical/biotechnology companies or CROs, for both sponsor-led and outsourced clinical studies, including non-interventional or interventional studies

 Experience in developing Data Management related deliverables, such as Clinical Report Forms (CRFs), Data Management Plans, Data Quality Review Plans, and other applicable plans and documents

 Experiencing in providing Data Management operational input into the study design, protocol and other study document development, study planning and implementation

 Experience in developing and implementing standards and processes (SoPs) is preferred

 Strong oral and written communication and presentation skills in Chinese and English.

 Other language skills are a plus

 Solid understanding of the scope and focus of clinical trials (Ph 1-4) and non-interventional studies, and has a track record of performing core Data Management tasks and interact with vendors

 Strong working knowledge of Data Management processes, EDC platforms (e.g., RAVE), and applicable regulatory and industry requirements (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, GCP, GPP) and their application to Data Management practice

 High attention to detail and the ability to work individually, within a multi-disciplinary team, and with external partners and vendors

 Ability to prioritize multiple projects and deliverables, along with effective time management skills

 Ability to effectively present information and respond to questions from project teams, sites, and external vendors

 Understanding of clinical medical concepts and terminology

 Proficiency in Microsoft® Office software

 Knowledge of document management processes and software (SAS or R)