Associate, Clinical Study Manager (Pharma/Onco)

Sep 09, 2021

Job Description

ノバルティスファーマ株式会社の治験実施部門である「Study Management Group」では、「Clinical Study Manager(CSM)」を募集しています。
CSMは日本のPhase I~IVの治験実施チーム(Local Trial Team)のリーダーとして、プランニング、管理(enrollment、budget、timeline)、必要資材の作成、モニタリング報告書のReview、治験届の作成等などのオペレーション業務行います。
さらに国際共同治験の場合は、Global Clinical Trial TeamとのCommunicationの窓口になり、StudyをManagementする役割を担います。

Major Accountabilities:
- In collaboration with the Trial Monitoring key takeholders (CSM Group Head, Regional Operations Manager (ROM), local/global medical, Trial Operations Manager (TOM), and global clinical assists in the development of local study execution plans and timeline commitments for a Country/Cluster
- Participates in the development of innovative solutions or site and patient participation to ensure the delivery of assigned studies on time allocation, initiation and conduct of trials
- Supports study feasibility and country patient commitments in collaboration with country/cluster Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study
- Leads site selection in collaboration with Country/Cluster Trial Monitoring and Medical
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
- Works with local Drug Supply Management, aligned with BPA, to forecast local IMP and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial/assigned trial sites
- Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues, escalating as necessary
- Ensures sites are prepared for “Ready to Initiate Site” (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
- Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans) to ensure all study operational aspects are on track

Job Profile:
- Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
- Oversees local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and nternational regulations
- Leads/chairs local study team meetings or supports Sr. CSM in the conduct of local study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies or study sites
- Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
- Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
- Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders

Delivery of quality data and compliance to quality standards:
- Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing
legislation, GCP, Ethical Committee and SOP requirements
- Conducts or coordinates local investigator meetings as needed
- Ensures documentation of training (global/regional/local investigator meeting minutes, participants’ lists, certificates, etc.) is archived in the Trial Master File
- Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/
escalating to regions and/or global teams, as appropriate
- Is the escalation point for issues in monitoring visit reports (MVRs) for the assigned studies, post CRA Manager review (may act as primary reviewer in countries where CRA Managers do not exist). Is responsible for evaluating trends identified in MVRs and communicating/escalating to regions and/or global teams, as appropriate.
- Communicates with CRAs and their managers to ensure issue resolution in a timelymanner
- Provides feedback about the quality of monitoring activities to CRA Managers and local QA as appropriate
- Supports inspection readiness and submission preparation for monitoring related activities and assists with internal audits and HA inspections, as required, and ensures implementation of corrective actions within specified timelines
- Participates in multidisciplinary taskforces to support continuous improvement initiatives

Minimum Requirements

A degree in scientific or health discipline required and
advanced degree with clinical trial experience and/or
project management, is preferable

Business Level Japanese and English (oral and

 Minimum 5 years’ experience in clinical research
in a role that oversees (project management)
and/or with monitoring clinical trials
 Capable of leading in a matrix environment,
without direct reports
 Understanding of all aspects of clinical drug
development with particular emphasis on
monitoring and study execution

 Strong project management capabilities with
demonstrated ability to problem solve and mediate complex issues
 Thorough understanding of the international
aspects of drug development process, including
strong knowledge of international standards
(GCP/ICH), health authorities (PMDA), local Health
Authorities regulations and Novartis standards

Skills & Knowledge:
 Demonstrated negotiation and conflict resolution
skills both internal and external (site relationships)
 Communicates effectively in a local/global
matrixed environment.

Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Global Drug Development
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Associate, Clinical Study Manager (Pharma/Onco)

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