Clinical Trials Management Specialist

2 weeks ago

Foster City, California, United States Rose International Full time

Minimum Education & Experience:

  • MA/ MS / PharmD / PhD with a minimum of 2 years of relevant clinical or related experience in life sciences.
  • BA / BS / RN with at least 4 years of relevant clinical or related experience in life sciences.
  • Proven experience in overseeing the work of external vendors.
  • Fulfillment of all criteria for the Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable expertise.

Required Skill Sets:

  • Experience in sample management.
  • Proficient in Microsoft applications.
  • Exceptional communication abilities.

Preferred Skill Sets:

  • Experience in clinical operations or bioanalytical operations.
  • Laboratory (bench) experience.

Position Overview:

The Clinical Operations department is accountable for the global execution of all Phase I - IV clinical trials across various therapeutic areas. This team plays a vital role in ensuring that all clinical trials are conducted in compliance with applicable SOPs, company policies, and regulatory guidelines, providing timely and high-quality clinical data that supports global registration and commercialization of products.

You will assist other Clinical Operations team members in the initiation, management, and conclusion of clinical studies. Your responsibilities may include managing specific components of clinical studies and serving as a member of the study team. You may also oversee vendors and/or manage investigator-sponsored research. Additional tasks may involve reviewing clinical study protocols and other study documents, contributing to SOP development, and participating in special projects.

Example Responsibilities:

  • Lead or manage components of Phase I, II, or III studies.
  • Assist Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinate all interactions and deliverables from vendors.
  • May serve as the operational contact for studies.
  • Plan and coordinate all operational activities related to the collection, delivery, and analysis of biological samples within a clinical trial.
  • Manage study timelines, including documentation and communications.
  • Act as the point of contact with internal and external stakeholders for the successful implementation of all biological sample analysis strategies in collaborative programs.
  • Participate in and manage project meetings and conference calls with CROs, other vendors, and cross-functional teams.
  • Engage in the functional review of study protocols and other study-related documents such as clinical sample management plans and study communication plans.
  • Contribute to the review and approval of main study and optional informed consents.
  • Assist in SOP development and participate in special projects.
  • Develop tools and processes that enhance project efficiencies and effectiveness.
  • Proactively identify potential operational challenges and collaborate with key stakeholders to provide solutions to ensure study execution remains on track with projected budgets and timelines.
  • Ensure compliance with established practices, policies, processes, and any regulatory requirements.

Knowledge & Other Requirements:

  • Demonstrated ability to learn quickly.
  • Flexibility and adaptability to change, with the ability to move between projects and provide support/expertise as needed.
  • Comprehensive understanding of full-cycle clinical study management, from initiation to conclusion, with a proven ability to apply this knowledge effectively.
  • Significant industry knowledge.
  • Thorough understanding of FDA and EMA regulations, ICH guidelines, GCP, and key Clinical Operations principles.
  • Familiarity with standard medical and scientific terminology.
  • Clear and concise communication skills.
  • Ability to thrive in a team-oriented, highly matrixed environment.
  • Capability to manage multiple tasks as assigned.
  • Willingness to travel when necessary.

Equal Opportunity Employment:

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

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