Johnson & Johnson キャリア
【Janssen】Japan R&D, Clinical Data Management Leader (Senior Specialist Level)
Requisition ID: 1805672255W
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. 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 multiple project.
Ensure the quality of clinical trial database, and deliver timely, accurate & secure database for
clinical development of the analysis.
・ 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.
・ Judgement of DBL
- 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 to 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 DM process improvement.
・ This position makes decisions for assigned trials 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.
・ External; DM-CRO, External vender, PMDA (eDATA submission)
Span of Control:
・ Number of assigned project: 6-7 including 2-3 active projects
Education and Experiences Requirements:
・ 6-8 years of pharmaceutical industry experience overall including clinical development experience.
・ 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 work with cross-functional team interpreting data requirements.
・ In-depth project driving skills and knowledge of team management principles are required.
・ Oral and written communication skills in both English and Japanese.
Janssen Pharmaceutical K.K. (7195)
Clinical Data Management