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Study Start Up Lead

South San Francisco, CA 94080

Posted: 05/13/2026 Employment Type: Contract Industry: Medical Affairs Job Number: 12635 Pay Rate: $46.00 - $87.00 Remote Friendly: Onsite

Job Description


Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

Duties:
  • Lead and execute country-level clinical trial start-up strategies, ensuring efficient, compliant initiation and activation of Roche-sponsored studies.
  • Oversee all start-up operations, including regulatory submissions, site activation, and amendment management, while aligning with global timelines and strategies.
  • Drive process improvements through automation, standardization, and innovation, and collaborate with cross-functional internal teams, CROs, and external stakeholders such as Ethics Boards and Health Authorities.
  • Manage and oversee informed consent form (ICF) processes, clinical trial documentation, and regulatory packages, ensuring accuracy, compliance, and timely submissions.
  • Coordinate site documentation, vendor activities, and translation/approval of study materials.
  • Provide strategic oversight of budgeting, contract negotiation, and financial planning, including fair market value assessments, contract execution, and payment processes.
  • Maintain compliance with country-specific regulations and ensure proper documentation throughout the study lifecycle.
  • Contribute to industry collaborations and engage with regulatory bodies to support clinical trial policy alignment.
  • In people management roles, provide leadership, coaching, performance management, and foster an inclusive, high-performing team environment.

Job Requirements


Skills:
  • Strong knowledge of clinical trial start-up processes, regulatory submissions, and compliance requirements (ICH-GCP, EU CTR, and local regulations).
  • Proven ability to manage cross-functional collaboration, vendor/CRO relationships, and complex project timelines.
  • Excellent organizational, analytical, and problem-solving skills, with attention to detail and the ability to manage multiple priorities.
  • Proficiency in clinical systems such as Veeva Vault, CTIS, and RIM.
  • Strong communication and interpersonal skills, with the ability to influence stakeholders and lead within matrixed global teams.
  • Demonstrated ability to drive process improvements and operate effectively in complex, ambiguous environments.
  • Fluency in English and the local country language is required.

Education:
  • Bachelor’s, Master’s, or advanced degree (MD, PhD) in life sciences or a related field.
  • Advanced or postgraduate degrees are highly desirable.
  • Relevant experience in clinical trial operations, start-up activities, or regulatory coordination is required, with experience level aligned to role seniority (typically 2+ years for early-career roles and 4+ years for more advanced positions).

Meet Your Recruiter

Lexie Pierce
Senior Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About South San Francisco, CA

Ready to take the next step in your career journey? Explore our job opportunities in the vibrant area surrounding South San Francisco, California! Known for its proximity to the iconic Golden Gate Bridge and the bustling tech hub of Silicon Valley, this region offers unrivaled growth potential and a dynamic work environment. With a unique blend of culture, including the renowned SFMOMA art museum, the lively Castro District, and delectable cuisine like the famous sourdough bread at Boudin Bakery, South San Francisco is the perfect place to thrive professionally while enjoying the beauty of nearby parks like Golden Gate Park and the breathtaking views of the Pacific Ocean. Join us in discovering the endless possibilities for your career in this enchanting region!