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Study Start Up Lead

Careers Integrated Resources Inc South San Francisco, CA (Onsite) Contractor
Job Title- Study Start Up Lead (SSUL)
Location- South San Francisco, CA
Duration- 12 months Contract
Client -Roche
Pay -$91/hr. on w2

Job Description: Study Start Up Lead (SSUL)
 
Key Responsibilities
  • This role focuses on the efficient and compliant initiation of Client-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 Client Leadership Framework, to a group of direct reports. By exemplifying our Client values, Leadership commitments and modeling our Client 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 Client 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.

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Job Snapshot

Employee Type

Contractor

Location

South San Francisco, CA (Onsite)

Job Type

Management

Experience

Not Specified

Date Posted

05/05/2026

Job ID

26-10773

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