【Janssen】 R&D Japan QS, Clinical Data Manager (Staff)

4-6 years of pharmaceutical industry experience overallincluding clinical development experience.

Knowledge of international guidelines regarding clinicaltrials (e.g. ICH guideline 21 CFR part11 ER/ES eDATA submission requirement)

In-depth knowledge of protocol and current clinical drugdevelopment processes

Working knowledge of data management system (EDC LSAFetc.)

Working knowledge of dictionary coding and understandingmedical dictionaries (e.g. MedDRA WHO-DD)

Ability to work with cross-functional team interpretingdata requirements.

In-depth project driving skills and knowledge of teammanagement principles are required.

Oral and written communication skills in both English andJapanese.

Qualification/Certificate

Janssen R&D Japan QS ClinicalData Manager (Senior Specialist)

Thisposition is an individual contributor that is responsible for taking leadershipin all clinical data management activities for assigned trial(s) and Japan NDAsubmission as representative from Data management function with minimalsupervision. Drive data management deliverables in a timely and efficientmanner in close collaboration with cross- functional counterpart.

Ensurethe quality of clinical trial database and deliver timely accurate &secure database for clinical development of the analysis with minimalsupervision.

Provide input around choice of ESP for data managementactivities for assigned trial(s) with minimal supervision and lead contractwith ESP.

Arrange to contract with DM CRO and other vendors (EDCPK office SD office etc.).

Provide Budget input for R&D budget planning exercisefor assigned trials with supervision.

Input possible and effective options at the point of datacollection and handling with minimal supervision as needed.

Identify the data necessary to meet the objectives of theprotocol and create an adequate eCRF format accordingly.

Lead to input study specific part with minimalsupervision.

Provide data management deliverables in collaborationwith Clinical Team;

Review CRF Completion Guideline Data Validation RulesData Transfer Agreement and other documents provided by DM-CRO/external vendor.

Review SDTM related documents and SDTM data to inputprotocol relevant requirement.

Assist physician with reviewing dictionary coding forAdverse Event Concomitant Medication Medical History etc. as needed.

Ensure required DM deliverables to be archived into TMFsystem in timely manner.

Perform all relevant data management review andcontinuously review the database contents by SDTM compliance checker andlisting including applicable tools.

Collaborate with appropriate representatives to review(e.g. medical review protocol deviations* dictionary coding*) *Verifyconsistency across the trials within the compound as applicable.

Through data review monitor whether desirable data iscollected or not and take necessary measures in timely manner.

Coordinate the locking and/or unlocking of the clinicaldatabase as required

Responsible for coordination of submission ready SDTMpreparation for eDATA submission schedule and requirement to in closecoordination and cooperation with the other involved

Ensure inspection readiness of all DM deliverables forthe trials. Participate PMDA inspection and internal audits and respond DMrelated inquiry as necessary.

Participate SME activities to contribute DM processimprovement.

DecisionMarking:

This position makes decisions for assigned trials orassignment with direction from the Data Management Head around processtimelines and budgets if decisions do not adversely impact on function or the qualityof deliverables with minimal supervision.

Her/ His decision impacts project timelines dataquality budget and resources in and out of Clinical data management.

External; DM-CRO External vender PMDA (eDATAsubmission)

Spanof Control:

Number of assigned projects: 4-5 including 1-2 activeprojects

Budget planning and management for assigned projects withsupervision.