Clinical Study Manager

328333BR
Oct 15, 2021
Hong Kong Special Administrative Region, China

Job Description

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend 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.

Your key responsibilities:
Your responsibilities include, but are not limited to:

Trial Monitoring strategy
•In collaboration with the Trial Monitoring key stakeholders (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 for 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. 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 international 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 comm unication, 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 protocol specific 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 protocol specific 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 accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation/resolution. Is the escalation point for issues in monitoring visit reports (MVRs) for the assigned studies.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 timely manner.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 and coordinates with country/cluster Trial Monitoring and Quality Assurance for internal audits organization and HA inspections, as required, and ensures implementation of corrective actions within specified timelines.Participates in multidisciplinary taskforces to support continuous improvement initiatives

Budget and productivity
•Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study start up under the direction of their manager. Tracks study budget with appropriate study budget responsible in Country/Cluster. Ensures timely TCF preparation and submission in collaboration with the TCF specialist in the Country/Cluster. Processes invoiceable items for site level clinical study activities to allow timely payments

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
•A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
•Fluent in both written and spoken English, local language as needed in clusters/countries
•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 (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
•Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
•Communicates effectively in a local/global matrixed environment

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis network: If this role is not suitable to your experience or career goals but
you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.
Global Drug Development
GDO GDD
Hong Kong Special Administrative Region, China
Hong Kong
Research & Development
Full Time
Regular
No
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328333BR

Clinical Study Manager

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