This position is a professional individual contributor that is responsible for taking leadership in all clinical data management activities for assigned trial(s) and Japan NDA submission as representative from Data management function. This position is also responsible for taking leadership in TA level and supervise CDML/ CDM as required. Drive data management deliverables in a timely and efficient manner in close collaboration with cross- functional counterpart.
Responsible for Data Management strategy, planning, execution of activities of assigned TA.
Ensure the quality of clinical trial database, and deliver timely, accurate & secure database for clinical development of the analysis.
・ Supervise CDML/ CDM in assigned TA to provide disease area insights and specifications to be secure Japan NDA submission.
・ Provide input around choice of ESP for data management activities for assigned trial(s) and lead contract with ESP.
・ Arrange to contract with DM CRO and other vendors (EDC, PK office, SD office etc.).
・ Provide Budget input for R&D budget planning exercise for assigned trials.
- Input possible and effective options at the point of data collection and handling.
- Identify the data necessary to meet the objectives of the protocol and create an adequate eCRF format accordingly.
- Lead to input study specific part.
- Provide consolidated requirement to eCRF builder.
・ Provide data management deliverables in collaboration with Clinical Team;
- Review CRF Completion Guideline, Data Validation Rules, Data Transfer Agreement and other documents provided by DM-CRO/external vendor.
- Develop the criteria of protocol deviations.
- Develop the Data Flow Diagram.
- Review SDTM related documents and SDTM data to input protocol relevant requirement.
- Train eCRF design and entry rules to site monitors.
- Assist physician with reviewing dictionary coding for Adverse Event, Concomitant Medication, Medical History, etc. as needed.
- Develop Database release plan.
- Manage to prepare archival CRFs.
- Ensure required DM deliverables to be archived into TMF system in timely manner.
- Perform all relevant data management review and continuously review the database contents by SDTM compliance checker and listing including applicable tools.
- Collaborate with appropriate representatives to review (e.g. medical review, protocol deviations*, dictionary coding*)
*Verify consistency across the trials within the compound as applicable.
- Through data review, monitor whether desirable data is collected or not, and take necessary measures in timely manner.
- Ensure appropriate quality for locked data.
- Coordinate the locking and/or unlocking of the clinical database, as required
- Responsible for coordination of submission ready SDTM preparation for eDATA submission schedule and requirement in close coordination and cooperation with the other involved representatives (e.g. RA, Biostat, CP, CSAD, PM).
- Explain contents errors at eData PMDA mtg.
- Ensure inspection readiness of all DM deliverables for the trials. Participate PMDA inspection and internal audits and respond DM related inquiry as necessary.
- Lead SME activities to contribute process improvement and work with Global team as business owner of local SME as required.
・ This position makes decisions for assigned TA or assignment with direction from the Data Management Head around process, timelines and budgets if decisions do not adversely impact on function or the quality of deliverables.
・ Her/ His decision impacts project timelines, data quality, budget and resources in and out of Clinical data management in TA.
・ External; DM-CRO, External vender, PMDA (eDATA submission)
・ Number of assigned projects: 6-7 including 2-3 active projects・ Budget planning and management for assigned TA.
Education and Experiences Requirements:
・ 6-8 years of pharmaceutical industry experience overall including clinical development experience.
・ In-depth Knowledge of international guidelines regarding clinical trials (e.g. ICH guideline, 21 CFR part11, ER/ES, eDATA submission requirement)
・ In-depth knowledge of protocol and current clinical drug development processes
・ Working knowledge of data management system (EDC, LSAF, etc.)
・ Working knowledge of dictionary coding and understanding medical dictionaries (e.g. MedDRA, WHO-DD)
・ Ability to lead cross-functional team interpreting data requirements.
・ In-depth project driving skills and knowledge of team management principles are required.
・ Strong oral and written communication skills in both English and Japanese.
・ Demonstrates influence, negotiation and conflict resolution skills.
Janssen Pharmaceutical K.K. (7195)