[Innovative Medicine] Analyst II, Analytical Monitoring, Data Management and Central Monitoring, Integrated Data Analytics & Reporting (IDAR), IM R&D

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Integrated Data Analytics and Reporting (IDAR)

Analyst II Analytical Monitor

Position Summary:

• The Analyst II Analytical Monitor is an individual contributor with knowledge of site monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies.
• Empowered by technology, optimized processes and targeted data analytics, Analytical Monitors will enable Site Managers to dedicate a greater proportion of their time for meaningful engagement with sites, driving improved performance, data reliability and site satisfaction.
• The Analyst II Analytical Monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. This position receives ongoing direction from their functional manager and/or other experts to achieve objectives.
• This position collaborates closely with Site Managers, other Data Management & Central Monitoring roles, & other internal partner functions and/or external service providers to achieve successful, cooperative partnerships.

Principal Responsibilities:

• Conducts activities in compliance with J&J functional SOPs, processes and policies.
• May support innovation or process improvement projects which may include but are not limited to requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.
• Facilitates smooth and effective communication, managing multiple communication streams. Follows agreed escalation pathways where needed.

Analytical Monitor Role-Specific Responsibilities:

• Performs analytical monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of execution and close-out as outlined in the end-to-end process. This may also include support in local language to enable effective collaboration & execution.
• Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence
• Collaborates closely with the Site Manager and Central Monitoring Manager to action trends and signals detected at the site and subject level.
• Accesses various systems, databases and reporting tools to identify potential risks related to the site and subject level data quality, study participant safety and compliance by identifying trends and early warning signals
• Provides timely analytical data insights to support the Site Managers in making decisions on site prioritization and critical engagement.

Principal Relationships:

• Functional contacts in J&J Innovative Medicine include but are not limited to Site Managers and Local Trial Managers.
• Functional contacts within IDAR include but are not limited to Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
• External contacts include but are not limited to External Service Providers.

Education and Experience Requirements:

Required

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences. Advanced degrees preferred (e.g., Masters, PhD).
• Approximately 4+ years experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Knowledge of trial site operations and study execution
• Working knowledge of regulatory guidelines (e.g., ICH-GCP).
• Demonstrated understanding of data analysis and familiarity with basic statistical concepts.
• Project, Issue, and risk management experience with ability to apply critical thinking & problem-solving skills, to drive solutions & helping to lead teams to successful outcomes.
• Experience working with technology platforms and systems used for the collection, analysis and reporting of data.
• Ability to effectively collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively.
• Strong ability to communicate effectively (written and verbal). 
• Good written and verbal communications skills (in English).
• Knowledge of clinical drug development processes.

Preferred Experience

• Working with complex data structures and reporting specifications
• Working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
• Possess proficiency in statistical analysis, data modelling, and data visualization techniques, or demonstrate strong knowledge in these areas.
• Knowledge of Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts

#LI-Hybrid

========================================================

社内公募ガイドライン

• 応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。

• 在籍期間に関わらず、書類選考を通して１次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。
• 社内紹介を行う場合は、Career Hub上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。