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Clinical Research Management Specialist

2 months 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 activities of external vendors.
  • Fulfillment of all qualifications for the Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable expertise.

Required Skill Sets:

  • Experience in sample management.
  • Proficient in Microsoft Office Suite.
  • Exceptional communication abilities.

Preferred Skill Sets:

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

Position Overview:

The Clinical Operations team is responsible for the global execution of all Phase I-IV clinical trials across various therapeutic areas. This team plays a crucial role in ensuring that all clinical trials adhere to applicable Standard Operating Procedures (SOPs), company policies, and regulatory guidelines, thereby providing timely and high-quality clinical data that supports global product registration and commercialization.

In this role, you will assist fellow Clinical Operations team members in the initiation, management, and closure of clinical studies. You may oversee specific components of clinical studies and collaborate as a member of the study team. Responsibilities may also include vendor management and oversight of investigator-sponsored research. You may contribute to the review of clinical study protocols and other study documents, assist in SOP development, and participate in special projects.

Key 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 Contract Research Organizations (CROs), other vendors, and cross-functional teams.
  • Contribute to the functional review of study protocols and other study-related documents such as clinical sample management plans and study communication plans.
  • Participate in the review and approval of main study and optional informed consents.
  • Contribute to SOP development and/or engage 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, ensuring study execution remains aligned 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 seamlessly and provide support/expertise as needed.
  • Comprehensive understanding of the full cycle of clinical study management, from initiation to closure, with proven ability to apply this knowledge effectively.
  • Significant industry knowledge.
  • Thorough understanding of FDA and EMA regulations, ICH guidelines, Good Clinical Practice (GCP), and key Clinical Operations principles.
  • Familiarity with standard medical/scientific terminology.
  • Clear and concise communication skills.
  • Ability to thrive in a team-oriented, highly matrixed environment.
  • Capacity to manage multiple tasks as assigned.
  • Willingness to travel when necessary.

Benefits:

For information and details on employment benefits offered with this position, please visit our website. If you have any questions or concerns, please contact our HR Department through our secure platform.

Equal Opportunity Employer:

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.