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.
What you will be doing:
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Initiation and conduct of trials
- When requested by the SSO Feasibility Manager 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), according to Novartis standards and relevant regulations, Leads/chairs country/cluster/hub 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
- 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, 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
- Collaborates with Clinical Research Associate (CRA) Manager to ensure that monitoring trends that require targeted training and/or development are escalated.
- Coordinates between the Clinical Research Associate (CRA) Manager, CPM and SSO Site Partnership Manager to ensure that site issues, data flow and commitment deviations are addressed and escalated.
- Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
- Manages CPM, SSO Feasibility Manager and SSO Site Partnership Manager adherence/compliance to SOPs and required training curricula
- Ensures any competency gaps are identified and resolved through targeted training curricula in collaboration with the training and Portfolio Execution Excellence group
- Supports CPO/site audits and inspections (as appropriate) related to CAPA follow-up and implementation of study level identified issues
You are:
- 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
- Experience/Professional requirement:
- Minimum 2 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 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
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
