Biomarker and Bioanalytical Clinical Operations Specialist

2 weeks ago

Foster City, California, United States Rose International Full time

Minimum Education & Experience:

  • Advanced degree (MA/MS/PharmD/PhD) in life sciences with relevant clinical experience.
  • Bachelor's degree (BA/BS) or Registered Nurse (RN) with at least one year of pertinent work experience.
  • Preferred background in general clinical or business knowledge.
  • Proficient in Microsoft Word, PowerPoint, and Excel.
  • Strong verbal, written, interpersonal, and presentation skills are essential.

Knowledge & Other Requirements:

  • Proven ability to learn quickly.
  • Flexibility and adaptability to changing priorities and projects.
  • Willingness to understand the biopharma industry.
  • Team-oriented with strong collaboration skills.
  • Excellent analytical and organizational capabilities.
  • Familiarity with FDA, EMA regulations, ICH guidelines, and GCP is advantageous.
  • Basic proficiency in office software and tools.
  • Clear and concise communication skills.
  • Ability to thrive in a team-focused, matrixed environment.
  • Capacity to manage multiple tasks effectively.
  • Willingness to travel as required.

Position Overview:

The Clinical Operations team is tasked with the global execution of all Phase I-IV clinical trials across various therapeutic areas. This team plays a critical role in ensuring compliance with SOPs, company policies, and regulatory guidelines to deliver timely and high-quality clinical data supporting global product registration and commercialization.

You will assist fellow team members in the initiation, management, and closure of clinical studies. Responsibilities include tracking and preparing study-specific information, reviewing data quality, organizing meetings, and contributing to document development.

Example Responsibilities:

  • Track and prepare study-specific information utilizing databases and spreadsheets.
  • Engage in quality assurance reviews of data and documents.
  • Coordinate meeting logistics, prepare agendas, and assist with minutes.
  • Collaborate with other departments to fulfill assigned tasks.
  • Support the creation of documents and standard forms.
  • Ensure compliance with established practices, policies, and regulatory requirements.
  • Work with cross-functional teams across therapeutic areas including Oncology, Inflammation, and Virology.
  • Assist in sample reconciliation for ongoing clinical studies in partnership with study leads.
  • Support eTMF filing and participate in oral presentations as necessary.

Benefits:

For details on employment benefits associated with this position, please visit our official website. For inquiries, contact our HR Department through the secure portal.

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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