Clinical Trials Operations 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 activities of external vendors.
  • Must fulfill all qualifications for the Clinical Trial Management Associate (CTMA) grade 25 position with demonstrated expertise.

Required Skill Sets:

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

Preferred Skill Sets:

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

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 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.

You will collaborate with other Clinical Operations team members in the initiation, management, and conclusion of clinical studies. Responsibilities may include managing specific components of clinical studies and participating as a member of the study team. You may also oversee vendor management and investigator-sponsored research activities. Additionally, you may assist in reviewing clinical study protocols and other study documents, contribute to SOP development, and engage 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.
  • Act as the operational contact for studies as needed.
  • 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.
  • Serve 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.
  • 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, and may review additional study-specific informed consents.
  • Assist in SOP development and/or 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 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 capacity to transition between projects and provide support where 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 and scientific terminology.
  • Ability to communicate clearly and concisely.
  • Capability to support a team-oriented, highly-matrixed environment.
  • Ability to manage multiple tasks as assigned.
  • Willingness to travel when necessary.

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.

  • Clinical Trials Operations 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. Must meet all qualifications for the Clinical Trial Management...

  • Clinical Trials Operations Specialist

    2 weeks ago

    Foster City, California, United States Rose International Full time

    Minimum Education & Experience:MA/MS/PharmD/PhD with over 2 years of relevant clinical or related experience in life sciences.BA/BS/RN with 4+ years of relevant clinical or related experience in life sciences.Proven experience in overseeing the work of external vendors.Meets all qualifications for Clinical Trial Management Associate (CTMA) grade 25 position...

  • Senior Clinical Trial Management Specialist

    2 weeks ago

    Foster City, California, United States Integrated Resources, Inc Full time

    Job OverviewPosition Title: Senior Clinical Trial Management SpecialistLocation: RemoteContract Duration: 06+ monthsCompensation: $60 - $64/hr. on W2Position Summary:As a Senior Clinical Trial Management Specialist, you will play a pivotal role in the execution of clinical trials across various phases, ensuring adherence to established protocols and...

  • Senior Clinical Trial Management Specialist

    2 weeks ago

    Foster City, California, United States LeadStack Inc. Full time

    Position Title: Senior Clinical Trial Management SpecialistDuration: 6 months with potential for extensionLocation: RemoteCompensation: $40-$55/hr on W2Department: Clinical Operations – Biomarker and Bioanalytical OperationsClinical Operations is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic areas. This...

  • 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...

  • Lead Clinical Trial Operations Manager

    2 weeks ago

    Foster City, California, United States Vakulatech Full time

    Position OverviewJob Title: Senior Clinical Trial Manager - Biomarker and Bioanalytical OperationsCompany: VakulatechJob Duration: 6 monthsCompensation: $45-$50/hr W2Visa Status: Open to all visa types except H1BsRole Summary:The Clinical Operations team is integral to the global execution of Phase I - IV clinical trials across various therapeutic areas....

  • Lead Clinical Trial Operations Manager

    2 weeks ago

    Foster City, California, United States Vakulatech Full time

    Position OverviewJob Title: Senior Clinical Trial Manager - Biomarker and Bioanalytical OperationsCompany: VakulatechJob Duration: 6 monthsCompensation: $45-$50/hr W2Visa Requirements: Acceptable for all visa types except H1BRole Summary:The Clinical Operations department is tasked with the global execution of all phases of clinical trials across various...

  • Lead Clinical Trial Manager

    2 weeks ago

    Foster City, California, United States Vakulatech Full time

    Position OverviewJob Title: Senior Clinical Trial Manager - Biomarker and Bioanalytical OperationsCompany: VakulatechRole Duration: 6 monthsCompensation: $45-$50/hr W2Visa Requirements: Open to all visa types except H1BOverview: The Clinical Operations team is pivotal in executing Phase I to IV clinical trials across various therapeutic areas. This role is...

  • Clinical Trial Manager, Clinical Operations- Virology

    2 months ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Clinical Trial Manager, Clinical Operations- VirologyUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients...

  • Clinical Trials Project Coordinator

    2 weeks ago

    Foster City, California, United States ATR International Full time

    Job OverviewPosition Title: Clinical Trials Project CoordinatorType: ContractCompensation: Competitive hourly rateDepartment: Clinical Operations – Biomarker and Bioanalytical OperationsPOSITION SUMMARY:The Clinical Operations team is pivotal in managing the global execution of all clinical trials across various therapeutic domains. This role is essential...

  • Clinical Trials Operations Manager

    2 weeks ago

    Daly City, California, United States PinkDx, Inc. Full time

    Job Title: Clinical Trial ManagerLocation: San Francisco Bay AreaJob Type: Full-TimeAbout PinkDx, Inc.:PinkDx is an innovative organization dedicated to enhancing women's health throughout their life stages. Our mission is to identify and address unique medical needs of women with scientific precision, aiming to deliver solutions that have a meaningful and...

  • Senior Clinical Study Management Specialist

    2 weeks ago

    Foster City, California, United States Hydrogen Group Full time

    Position Overview:A prominent Biopharma organization is in search of a dedicated individual to take on the role of Senior Clinical Study Management Specialist. This position is structured as a contract opportunity with a competitive compensation range based on experience.The successful candidate will collaborate with Clinical Operations team members...

  • Clinical Operations Specialist in Biomarker Research

    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.General knowledge of clinical processes and business practices is advantageous.Proficiency in Microsoft Word, PowerPoint, and Excel is...

  • Biomarker and Bioanalytical Clinical Operations Specialist

    2 weeks ago

    Foster City, California, United States Rose International Full time

    Minimum Education & Experience:MA/MS/PharmD/PhD with relevant clinical or related experience in life sciences.BA/BS/RN with 1 or more years of pertinent work experience.General clinical or business knowledge and experience is preferred.Proficient in Word, PowerPoint, and Excel.Strong verbal, written, interpersonal, and presentation skills are...

  • Clinical Operations Associate

    2 weeks ago

    Foster City, California, United States Integrated Resources, Inc Full time

    Job Title: Clinical Project Associate - IIJob Location: RemoteJob Duration: ContractPay Rate: $40 - $45/hour on W2FUNCTION:Clinical Operations – Biomarker and Bioanalytical OperationsPosition Overview:Clinical Operations is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic areas. This department is crucial in...

  • Clinical Research 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 activities of external vendors. Fulfillment of all qualifications for the Clinical Trial...

  • Clinical Operations Associate

    2 weeks ago

    Foster City, California, United States Integrated Resources, Inc Full time

    Job Title: Clinical Project Associate - IIJob Location: Not specifiedJob Duration: 12 Months (Possible extension)Pay Rate: $40 - $45/hour on W2FUNCTION:Clinical Operations – Biomarker and Bioanalytical OperationsPosition Overview:The Clinical Operations team is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic...

  • Clinical Research Associate

    2 weeks ago

    Foster City, California, United States Integrated Resources, Inc ( IRI ) Full time

    Position Title: Clinical Project Assistant (CPA) - Biomarker & BioanalyticalDuration: 12 monthsLocation: Foster City, CAKey Responsibilities:The Clinical Project Assistant will provide essential support to the biomarker and bioanalytical operations team. Responsibilities include:Executing routine tasks under general supervision while following detailed...

  • 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,...

  • Clinical Operations Specialist in Biomarker and Bioanalytical Studies

    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 applicable work experience.General knowledge of clinical processes and business operations is advantageous.Proficiency in Microsoft Word, PowerPoint, and Excel is...