332330BR Job ID : 332330BR Job Description : Position 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.
Major accountabilities 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 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 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 Key Performance Indicators
Timely submission and delivery of high quality clinical trial documentation / data
Performance against study commitments at the country / cluster level, including delivery of studies per defined timelines (including study close out), number of patients and quality
Delivery of study milestones in adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements n n n n Position Title : Clinical Study Manager Minimum requirements :
Education : A degree in scientific or health discipline required and advanced degree with clinical trial experience and / or project management, is preferable
Languages : English
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 Job Type : Full Time Country : Argentina Work Location : Capital Federal Functional Area : Research & Development Division : Global Drug Development Business Unit : GDO GDD Employment Type : Regular Company / Legal Entity : Novartis Argentina S.
A 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.
Shift Work : No Early Talent : No