What are the responsibilities and job description for the Study Start Up Lead position at IT Engagements, Inc.?
Greetings from IT Engagements IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients. Job Summary Job Title: Study Start-Up Lead Work Location: South San Francisco, CA Description
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 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
Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.
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.
Thanks
Divya
divya@itengagements.com
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 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
Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.
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.
Thanks
Divya
divya@itengagements.com