Study Start Up Lead

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.

Responsibilities:
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.

• Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Oversee start-up operations and ensuring timely and efficient site activation and regulatory compliance.
• Ensure alignment with global strategies and timelines.
• Manage amendments throughout the study lifecycle.
• Identify and driving 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 to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).
• 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.
• Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices
• 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.
• 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
• 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.
• Provide coaching, support, and leadership, as part of the firm Leadership Framework, to a group of direct reports. By exemplifying our firm values, Leadership commitments and modeling our firm 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 firm 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.

Required Skills:

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.
• Early in career with at least 2 years of relevant experience in clinical trial operations.
• Established in a career with at least 4 years of relevant clinical trial operations in process and/or compliance and/or audit and inspections and/or vendor management and/or systems and/or learning.
• 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)
• 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.
• Project/Study Activities (Global Grade 5) (Global Grade 6)
• 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, Google Cloud Platform, regulatory guidelines within a clinical trial or enabling activity.
• Understands, problem solves, applies proficient knowledge of, and ensures adherence to ICH, Google Cloud Platform, 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.
• Has knowledge of other business functions in the organization and learns the upstream and downstream impacts of their team's decisions, including resourcing, on other parts of the business
• Awareness of clinical operations and the industry including key organizational drivers as well as the relevant processes, customers, and products related to their area of focus.
• Has knowledge of best practices and the role of clinical operations in product development; is aware of the clinical operations industry.
• Independently with minimal supervision capable of prioritizing workload
• Independently prioritizes their own work and effectively influences the team to develop plans for executing clinical trial infrastructure projects.
• Provides informal guidance to new and existing team members.
• Developing leadership skills, mentoring, and coaching colleagues with less experience, and provide

Preferred Skills:

• Postgraduate degree or master's degree highly desirable

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.