Study Start Up Lead
3 days ago
South San Francisco
Job DescriptionJob Description: Study Start Up Lead (SSUL) South San Francisco, CA 12 Months Description Organization Pharma - Product Development - Global Clinical Operations (PDG) Reports to Clinical Operations Country Head/Country Start Up Team Leader Location(s) PDG Countries Purpose, Objectives and Scope of Position As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role. Key Responsibilities This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance. Key responsibilities include: Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders. Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance. Ensuring alignment with global strategies and timelines. Managing amendments throughout the study lifecycle. Identifying and driving opportunities for process automation, standardization, and innovation. Collaborating with regional and global counterparts to harmonize systems and improve timelines. Participating in external industry collaborations to influence country start-up environments. Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities). You will lead in a cross functional environment in multiple of the following areas below: 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 you are 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 behaviours 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 Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master s degree highly desirable Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration Strong understanding of ICH-GCP, EU CTR, and local regulatory environments Experience managing vendor/CRO relationships Proven leadership or line management experience (for PLs) Skills & Competencies Excellent communication and interpersonal skills Strong organizational, analytical, and problem-solving capabilities Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.) Collaborative and adaptable mindset with attention to detail Ability to lead through complexity and ambiguity, especially in matrixed and global teams Fluency in written and spoken English is mandatory. Fluency in written and spoken language(s) of the host country is mandatory. IMPACT LEVELS Project/Study Activities (Global Grade 5) Project/Study Activities • Developing an understanding of is needed to support study start-up in clinical trials and drug development, which includes building awareness of the clinical trial industry and how clinical trials are operationalized., • Has a current comprehensive working knowledge of the clinical trial study start up processes needed to conduct clinical trials and drug development. Has awareness of the clinical trial industry and how clinical trials are operationalized., • Is building subject matter expertise specific to clinical trial study start up support through supporting the execution of start-up for country clinical trials., • Coordinates continuous improvement and change management activities to solve complex problems and brings their perspectives., • May require guidance and direction to support the execution of clinical trial study start-up projects. Has the basics to be able to prioritize their own work., • Demonstrates subject matter expertise on specific clinical operations start up activities through supporting the execution of global clinical trials., • Identifies, contributes to and participates in continuous improvement and change management activities to solve complex problems and bring new perspectives., • Independently and with minimal guidance is able to prioritize their own work and influence the team to develop plans to support the execution of clinical trial study start up projects., • Facilitates collaboration across PDG to effectively deliver on project requirements., • Collaborates across PDG and other functions in the delivery of the portfolio, • Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP, regulatory guidelines within a clinical trial or enabling activity., • Understands, problem solves, applies proficient knowledge of, and ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials., • Growing knowledge of other business functions in the organization and learning the upstream and downstream impacts of their team s decisions, including resourcing, on other parts of the business. #TB_PH #ZRHC #Linkd Why TalentBurst? At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce. Company DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CAFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA