Country Study Start up Team Leader, USA

Position Overview

The cSTL is responsible for the overall governance and oversight of study start-up activities in the United States. This role involves close collaboration with the US Country Head and US Leadership Team to ensure that the study start-up strategy aligns with GCP and regulatory requirements. As the leader of the PDG US Country Study Start-Up Team, the cSTL's main objective is to drive efficient study start-up processes, facilitating the delivery of clinical trials to patients. This includes enabling innovative clinical trial delivery, addressing start-up needs across all therapeutic areas, and ensuring seamless trial execution for patients, investigators, and clinical site staff. Strong collaboration with local internal and external country teams, global study teams, and CROs is crucial for this role. The cSTL focuses on the efficient and compliant initiation of Roche-sponsored clinical trials. This is achieved by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at both the country and site levels, all while maintaining regulatory compliance. This position is central to optimizing our country operations and achieving operational excellence, particularly in study start-up activities, to enhance performance, productivity, and business impact. This role works in collaboration with the US Leadership Team and other key stakeholders supporting Portfolio Delivery, such as Therapeutic Area Heads, Analytics and Performance partners, Clinical Operations Excellence, and US Medical Affairs' partners.

Role Responsibilities

Study Start-Up Strategy & Execution : Lead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners.

Informed Consent Form (ICF) Management : Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices.

Clinical Trial Submissions & Regulatory Coordination : Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.

Site Documentation & Compliance : Strategically manage site documentation and compliance, overseeing document collection / validation, coordination of related processes, and local vendor management (excluding CROs) if needed. Oversee translation and approval of drug labels and patient-facing materials, as required. Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs.

Budgeting & Contract Management : Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity / insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting.

Payment Oversight : Strategically oversee the payment processes, escalations, and reporting, ensuring financial / regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.

If selected as a People Leader (People Manager), in addition to the expectations outlined in this document you will also :

Provide coaching, support and leadership, as part of the Roche Leadership Framework, to a group of direct reports. By exemplifying our Roche values, Leadership commitments and modeling our Roche Operating Principles, you will ensure we achieve our ambitions for our people and patients. Conduct a regular year-round assessment of performance, contributions, and impact and provide feedback, coaching, and performance management. Lead by example in demonstrating and championing inclusive behaviors in your team, PDG, PD, and the Roche Enterprise. Provide opportunities for growth and development for all team members and address any barriers that may exist. People management-related administration (e.g. Workday People & Culture Management system tasks) and contact for employment-related matters.

Qualifications

Typically seen as an expert, advanced in career with 10+ years of relevant experience in process and / or compliance and / or vendor management and / or systems and learning. Exhibits a high degree of autonomy in prioritizing responsibilities with limited oversight, while expertly steering the team in crafting comprehensive strategies to enhance the execution of clinical trial infrastructure projects. Has in-depth and broad drug development knowledge and is recognized as a technical expert in Clinical Operations or related areas of expertise. Able to anticipate business, organization, vendor, and regulatory issues and recommend, implement and embed products, processes, and / or service improvements. Architects, leads, mentors, and coaches high-performing clinical trial or molecule program teams and / or complex enabling projects. Develops an operational strategy for project clinical trial or enabling project execution. Leads others in resolving complex or highly complex outcomes that may have cross functional organizational implications and influences senior stakeholders to adopt a new approach.

This position is based in South San Francisco, CA. This is an on-site role. The expected salary range for this position based on the primary location of South San Francisco, CA is $188,400 - $349,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.