Sign upLog in

Study Start Up Lead

Apollo Professional Solutions

South San Francisco, CA

Apply
JOB DETAILS
SKILLS
Analysis Skills, Automation, Best Practices, Biology, Biotech and Pharmaceutical, Budgeting, Change Management, Channel Strategies, Click Through Rate (CTR), Clinical Information Systems, Clinical Support, Clinical Trial, Coaching, Communication Skills, Continuous Improvement, Contract Management, Contract Research Organization (CRO), Document Management, Documentation, English Language, Establish Priorities, Financial Compliance, Financial Planning, Forecasting, GCP (Good Clinical Practices), ICH Regulations, Informed Consent, Leadership, Legal, Maintain Compliance, Management Strategy, Medical Equipment, Medical Products, Mentoring, Negotiation Skills, Organizational Skills, People Management, Performance Analysis, Performance Management, Performance Reviews, Problem Solving Skills, Process Improvement, Product Development, Reconciliation, Regulations, Regulatory Requirements, Regulatory Submissions, Risk Analysis, Software Administration, Startup, Supplier Relationship Management (SRM), Team Lead/Manager, Time Management, Validation Documentation, Vendor/Supplier Management, Vendor/Supplier Relations
LOCATION
South San Francisco, CA
POSTED
14 days ago
Contract Study Start-Up Lead (SSUL)
Location: Client Site (Country-Based)
Function: Pharma | Product Development | Global Clinical Operations
Reports To: Clinical Operations Country Head / Country Start-Up Team Lead
Employment Type: Contract
About the Role
We are seeking an experienced Study Start-Up Lead (SSUL) to support the efficient initiation and execution of global clinical trials at the country level. In this high-impact role, you will drive study start-up strategies, oversee regulatory and site activation activities, and collaborate closely with country, regional, and global stakeholders to ensure timely delivery of clinical trials to patients.

This position is ideal for professionals with strong clinical operations expertise who thrive in cross?functional, matrixed environments and are passionate about improving clinical trial start?up timelines through innovation, compliance, and collaboration.
Key Objectives
As a core member of the Country Study Start-Up Team, you will:
  • Enable efficient, compliant, and patient?focused clinical trial start-up activities
  • Support innovative clinical trial delivery across multiple therapeutic areas
  • Ensure seamless execution for investigators, sites, and clinical teams
  • Act as a strategic partner to global study teams, vendors, and CROs
Key Responsibilities Study Start-Up Strategy & Execution
  • Lead and implement the country-level study start-up strategy aligned with global objectives and timelines
  • Drive efficiency, innovation, and continuous improvement in study start-up processes
  • Identify risks early and proactively implement mitigation strategies
  • Oversee and track full start-up execution in collaboration with CRO partners
Regulatory Submissions & Compliance
  • Lead the development, submission, and maintenance of clinical trial applications, amendments, and regulatory documentation
  • Act as the primary liaison with Ethics Committees, Health Authorities, and institutional bodies
  • Ensure compliance with ICH-GCP, EU CTR, and all applicable country regulations
  • Maintain up-to-date regulatory knowledge across medicinal products, medical devices, and IVDR requirements
Informed Consent Form (ICF) Management
  • Oversee preparation, submission, approval, and archiving of ICFs
  • Ensure alignment with regulatory, ethical, and corporate standards and best practices
Site Activation & Documentation
  • Strategically manage site documentation collection, validation, and compliance
  • Oversee translation and approval of patient-facing materials and drug labels, as required
  • Manage local vendors (excluding CROs) to support start-up activities when applicable
Budgeting, Contracts & Financial Oversight
  • Lead study start-up budgeting and contract strategies using Fair Market Value principles
  • Draft, negotiate, and implement site budgets, contracts, confidentiality agreements, and amendments
  • Ensure legal and financial compliance in collaboration with internal and external stakeholders
  • Maintain accurate contract and budget data to support forecasting and planning
Payment Oversight
  • Oversee investigator and site payment processes, reporting, and escalation activities
  • Participate in financial planning, reconciliation, and compliance reviews
Collaboration & Industry Engagement
  • Partner with global and regional teams to harmonize systems, processes, and timelines
  • Contribute to cross?company and external industry initiatives to improve country start-up environments
  • Support process automation, standardization, and innovation initiatives
People Leadership (If Applicable)
For candidates with line management responsibilities, additional expectations include:
  • Coaching, mentoring, and performance management of direct reports
  • Delivering regular feedback and year?round performance assessments
  • Promoting inclusive behaviors and equitable growth opportunities
  • Supporting employee lifecycle administration and employment-related matters
Impact & Career Level Global Grade 5
  • Builds foundational and growing expertise in clinical trial start-up activities
  • Supports country start-up execution with guidance
  • Contributes to continuous improvement initiatives
  • Independently prioritizes workload with developing influence skills
Global Grade 6
  • Demonstrates advanced subject matter expertise in study start-up operations
  • Independently leads start-up activities and influences cross?functional teams
  • Drives change management and process optimization initiatives
  • Facilitates collaboration across functions and portfolios
Qualifications Education
  • Bachelor’s degree in Life Sciences or related field (required)
  • Advanced degree (MD, PhD, MS/MA) strongly preferred
Experience
  • Minimum 2 years (Grade 5) or 4+ years (Grade 6) of clinical trial operations experience
  • Proven experience in study start-up, regulatory submissions, and site activation
  • Experience managing vendors and CRO relationships
  • Line management or people leadership experience (for leadership roles)
Required Skills & Competencies
  • Strong knowledge of ICH-GCP, EU CTR, and local regulatory requirements
  • Expertise with clinical systems (e.g., CTIS, Veeva Vault, RIM platforms)
  • Excellent communication, organizational, and stakeholder management skills
  • Analytical mindset with strong problem?solving abilities
  • Ability to lead through complexity and ambiguity in global, matrixed teams
Language Requirements
  • Fluency in written and spoken English (mandatory)
  • Fluency in the local country language (mandatory)
Why Join?
This is a unique opportunity to make a meaningful impact on clinical trial delivery while working at the intersection of strategy, compliance, and innovation. You’ll collaborate with diverse global teams, influence end?to?end trial start?up activities, and contribute directly to bringing new therapies to patients faster.

About the Company

A

Apollo Professional Solutions

Apollo Professional Solutions was founded by Gayle A. Williams in 1983 as a technical staffing firm supporting New England aerospace companies. Today, Apollo has grown into a $40 million year company, with 5 regional offices nationwide that offers diversified support to industries that include: defense, military, aeronautical, civil, food & beverage, healthcare, marine, pharmaceutical and scientific industries, as well as local government. We are an equal opportunity employers, that is also certified as a Women’s Business Enterprise by WBENC as well as the State of Massachusetts (SOWMBA Office.)
COMPANY SIZE
100 to 499 employees
INDUSTRY
Other/Not Classified
FOUNDED
1983
WEBSITE
http://apollopros.com/

Resume Resources

Free Resume TemplatesFree Resume Builder