職位描述
Job Purpose:
Under the direction of the Clinical Study Manager Group Head, or equivalent, the Clinical Study Manager is accountable for the day to day planning, executing and reporting, (from site feasibility up to and including study site close-out), of assigned Innovative Medicines Phase I-IV Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements.
The CSM is the single point of contact and local study team lead, within the Country/Cluster, for the assigned studies. The CSM is responsible for assuring aligned communication with Country/Cluster Clinical Research Associates (CRAs), CRA Managers and other key Country associates on the execution and progress of their studies. The CSM is accountable to communicate with and support relationships with clinical investigators. The CSM collaborates with Country medical/clinical trial colleagues on the execution and delivery of their assigned studies.
Your Key Responsibilities:
1. 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
2. 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 communication, when necessary
- Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
3. 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 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
4. 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
Desirable requirements:
1. Education: A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
2. Languages: Fluent in both written and spoken English, local language as needed in clusters/countries
3. Experience/Professional requirement:
- 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
4. Competencies:
- 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
5. 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?
750 million. 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
