Study Start Up Lead

Type: Contract, W2 only

Duration: 12 months

Location: South San Francisco, CA

Pay: $49/hr-$92/hr, DOE

Please note that at this time we are unable to sponsor employment authorization (both new and transfer)

As a member of the Product Development - Global Clinical Operations Country Study Start-Up Team, the SSUL drives and facilitates efficient study start-up processes that contribute to the delivery of clinical trials to patients. The role enables innovative clinical trial delivery, addresses study start-up needs across various therapeutic areas, and ensures seamless trial execution for patients, investigators, and clinical site staff. The SSUL focuses on the efficient and compliant initiation of the company-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. Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role.

Responsibilities:

• Lead teams in creating the study start-up strategy and executing the start-up process - including strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners.
• Architect and strategically oversee ICF management - preparation, submission, and archiving - to ensure compliance and alignment with corporate requirements and best practices.
• Lead the development and oversight of clinical trial submissions, amendments, and regulatory coordination - managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.
• Strategically manage site documentation and compliance - overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) where 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.
• Provide comprehensive strategic planning, oversight, and implementation for all aspects of budgeting and contract management - including developing Fair Market Value-based budget strategies, drafting clinical site budgets, negotiating and implementing contracts, CDAs, indemnity/insurance documentation, and amendments.
• Ensure financial and legal alignment through collaboration with internal and external stakeholders.
• Maintain accurate contract data in systems to support effective planning and forecasting.
• Strategically oversee payment processes, escalations, and reporting - ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.
• Lead country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Identify and drive opportunities for process automation, standardization, and innovation.
• Collaborate with regional and global counterparts to harmonize systems and improve timelines.
• Participate in external industry collaborations to influence country start-up environments.
• Engage with government and institutional bodies (Ethics Boards, Health Authorities) to align on clinical trial policies and practices.

Qualifications:

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.
• At least 2 years of relevant clinical trial operations experience.
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
• Experience managing vendor/CRO relationships.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.).
• Ability to lead through complexity and ambiguity, especially in matrixed and global teams.

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.