JOB ACCOUNTABILITIES:
1. Lead Data Management Activities; Perform Training and Client Relationship Management
1) Develop and maintain the Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow-up on their resolutions.
2) Act as the primary contact person for day-to-day data management activities and the person ultimately responsible for all data management deliverables for assigned projects.
3) Act as the primary contact person for communication and discussion of topics related to data management timelines and deliverables; requests for out-of-scope tasks; and the first line contact for technical or procedural issues.
4) Plan and implement data management timelines and deliverables; providing database and data management activities status reports; and contribute to the overall project planning, progress tracking, and reporting.
5) Assist with study-level resource planning and management, including the review of team members’ timesheet reports.
6) Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
7) Perform training on electronic data capture (EDC) system, dataflow, and quality control processes to clinical trial personnel.
8) Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
9) Assist in the generation of project Work Orders and Amendments.
10) Assist in the management of dataflow from and performance of third party vendors (non-CRF data vendors).
11) Participate in project kick off meeting, investigators meeting, and regular project management team meetings.
12) Provide support to client audits and regulatory inspections. Follow-up on audit findings.
13) Create and maintain clinical trial Data Management Study Binders.
2. Perform Hands-on Data Management Activities
1) Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
2) Design and review Clinical Trial Source Document templates and completion instructions when required.
3) Develop and maintain data validation specifications.
4) Develop and maintain the Data Management Plan (DMP). Document deviations from the DMP.
5) Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).
6) Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
7) Develop and maintain the Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
8) Perform third-party non-CRF data management activities.
9) Review data; issue and resolve queries. Assist investigative site personnel with resolving queries.
10) Perform serious adverse event (SAE) reconciliation.
11) Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events (AEs), procedures, and medicinal products.
12) Cooperate with and assist the quality assurance department with QC audits on assigned databases.
13) Perform database soft-lock and hard-lock activities.
14) Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.
QUALIFICATIONS:
1. A Bachelors’ or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
2. At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 years of experience as a Clinical Data Manager II, with demonstrated knowledge, experience, and ability to perform to meet high quality standards and high level of customer satisfaction.
3. Demonstrate an in-depth understanding of clinical trial data management concepts, processes and procedures, and relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.
4. Demonstrate a strong leadership in clinical data management activities and a desire to excel in leading data management projects.
Location: Shanghai or Other cities (Remote)