Study Start-up Manager M/W

Job title:

Study Start-up Manager M/W

Company

Novartis

Job description

Job Description Summary The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in France. The Study Start-Up Team Lead is supporting the country SSU strategy and prioritization in close collaboration with SSU Head and Country Leadership Team to deliver operational excellence of the Global Drug Development portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.Location : Rueil-Malmaison, Hybrid WorkingJob DescriptionResponsibilities:Your responsibilities include, but are not limited to:Study Start-Up Strategy

• Supports Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact

• Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations

• Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)

Allocation, initiation and conduct of trials

• Collaborates with Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments

• Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness

• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

People and resource management

• Hiring, training, development, and retention of Study Start-Up associates

• Resource management and reporting of Study Start-Up associates

• Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives

What you’ll bring to the role:

• Minimum 5 years’ experience in clinical operations and planning

• Proven leadership capabilities and experience

• Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring

• 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

Desirable requirements:A degree in scientific or health discipline requiredFluent in both written and spoken English and FrenchYou’ll receive:Salary range : 70 240€ -105 360€An annual bonusA focus on your career developmentAccess to our Quality of Life at work programFlexible workingAdvanced social coverage for you and your loved ones27 days of paid leave & 14 days of RTT per yearVarious employee recognition programsCommitment to Diversity & Inclusion:Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:Skills Desired Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model

Expected salary

Location

Paris

Job date

Thu, 20 Feb 2025 05:47:25 GMT

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