Johnson & Johnson Careers

【Janssen】Japan R&D, Clinical Data Management Leader (Senior Specialist Level)

Chiyoda, Japan
Clinical Data Management


Job Description

Requisition ID: 1805672255W

職務内容:
臨床試験のデータマネジメント業務
国内外CRO・その他ベンダーマネジメント(バジェットの管理を含む)
CRF 設計・データベースの構築指示、データレビュー、コーディングレビュー、電子データ申請準備、等
 
Position Summary:

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

 

Major Responsibilities:

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.

 
Accountability:

・ 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.

・ PED/Protocol Review;

- Input possible and effective options at the point of data collection and handling.

・ CRF design;

- 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.

・ Data Review

- 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

・ NDA submission

- 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.

・ SME activities

- Lead SME activities to contribute DM process improvement.

 

Decision Marking:

・ 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.

Influence:

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

Interface:
・ Internal; QS, JCO, CS, RA, Global counterpart

・ External; DM-CRO, External vender, PMDA (eDATA submission)

Span of Control:

・ Number of assigned project: 6-7 including 2-3 active projects

・ Budget planning and management for assigned projects.
・ Headcount: not applicable


Qualifications
業務経験
-医薬品開発に関する実務経験6 年以上
-データマネジメントに関する実務経験3 年以上。システムセットアップからデータ
ベースロック、および申請・適合性調査までを中心となって実行した経験を有する
-社内外の海外の担当者との業務経験を有する
-業務改善等のプロジェクトをリードした経験を有する
 
知識・技能
-データマネジメント業務を実施するための臨床的知識・規制要件を熟知している
-プロジェクト管理能力
-コミュニケーションスキル
部門の代表としてプロジェクトチームに貢献し、必要なインプットが出来る事
海外を含む社内外の関係者と適切なコミュニケーションがとれる事
-データマネジメントシステムに関する知識・使用経験
-ビジネス英語
 
 
Position Qualifications:

Education and Experiences Requirements:

・ M.S. or equivalent is required.

・ 6-8 years of pharmaceutical industry experience overall including clinical development experience.

・ Minimum 3 years of experience in data management.
 

Knowledge Requirements:

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

・ Proven knowledge of good data management practice

・ 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)

・ Working knowledge of SDTM and understanding SDTM IG
・ Vendor management oversight experience

・ 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.



Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Clinical Data Management
Requisition ID
1805672255W