Job Description

100,000. That\'s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients\' lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO

The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements.
The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies. The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager and SSO Site Partnership Manager in the planning, execution, and delivery of their assigned studies. Accountable for execution and reporting of assigned GDD studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM - CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.

Your responsibilities include, but are not limited to:

• Study & Site Operations strategy: Supports SSO Study Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments. Participates in the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time. Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub and develops respective mitigation plans
• Initiation and conduct of trials: supports the study feasibility by providing input to the study protocol, and operational aspects of the study. Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country/Cluster/Hub personnel. Drives the conduct of the study, (tracks status, maintains relevant 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 getting approval from the STUDY LEADER on enrolling above site targets. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan. Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate). Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, is the single point of contact for the conduct of assigned studies
• Maintains oversight of country/cluster/hub 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 CRAs and their managers to ensure proper documentation and communication. 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 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 and ensures relevant documentation of training is archived in the Trial Master File. Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, develops risk management plans and communicates/ escalates to global teams and SSO Hub Head Portfolio;
• 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. Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, always ensuring human subject protection and reliability of trial results. Escalation point for issues in monitoring visit reports (MVRs) for the assigned studies. Responsible for evaluating trends identified in MVRs and communicating/escalating to 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, MSOM, SSO Country Managers, FSP/BiS line managers and local QA. Supports inspection readiness and submission preparation for monitoring related activities and assists and coordinates with country Portfolio Execution 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 conduct. Tracks study budget with appropriate study budget responsible in Country. Ensures timely TCF preparation and submission. Processes invoiceable items for site level clinical study activities to allow timely payments.

Minimum requirements

• 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 and French;
• Solid 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 and working cross-border managing study in various countries. 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/EMA), local/National Health Authorities regulations and Novartis standards;
• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships), and communicates effectively in a local/global matrixed environment.

#GCO

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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.

We are an equal opportunities employer and welcome applications from all suitably qualified persons.

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, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GCO GDD

Employment Type

Regular

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

Novartis