Software Guidance & Assistance, Inc., (SGA), is searching for a Study Start-Up Lead for a contract assignment with one of our premier Pharmaceutical clients in South San Francisco, CA .
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.
Responsibilities :
- Focuses on the efficient and compliant initiation of firm-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.
- 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
- 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
- Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.
Required Skills :
- 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-Google Cloud Platform, 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.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy
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