Current jobs related to Clinical Trial Associate - San Mateo - ACL Digital

  • Clinical Trials Associate

    2 weeks ago

    San Diego, California, United States Janux Therapeutics Full time

    Clinical Trials Associate Job DescriptionJanux Therapeutics is seeking a highly motivated and detail-oriented Clinical Trials Associate to join our team. As a Clinical Trials Associate, you will play a key role in the planning and management of clinical trials, ensuring compliance with company policies and applicable regulations.Key Responsibilities:Support...

  • Clinical Trials Associate

    2 weeks ago

    San Diego, California, United States Janux Therapeutics Full time

    Clinical Trials Associate Job DescriptionJanux Therapeutics, Inc. is seeking a highly skilled Clinical Trials Associate to join our team. As a key member of our clinical operations team, you will play a critical role in the planning and management of clinical trials.Key Responsibilities:Support clinical operations project teams in planning and managing...

  • Clinical Trials Manager

    7 days ago

    San Mateo, California, United States Aerogen Full time

    About AerogenAerogen is a world leader in acute care aerosol drug delivery, headquartered in Galway, Ireland, with offices around the globe. Our team is committed to delivering innovative solutions to complex problems, with a focus on patient care.Job SummaryWe are seeking a Clinical Trial Manager to join our team, responsible for the recruitment,...

  • Clinical Trials Associate

    2 weeks ago

    San Diego, California, United States Janux Therapeutics Full time

    Clinical Trials Associate Job DescriptionJanux Therapeutics, Inc. is seeking a highly motivated and organized Clinical Trials Associate to join our team. As a key member of our clinical trial team, you will be responsible for providing administrative and operational support throughout the duration of a clinical study.Key Responsibilities:Support clinical...

  • Clinical Trials Manager

    2 weeks ago

    San Mateo, California, United States Aerogen Full time

    About AerogenAerogen is a world leader in acute care aerosol drug delivery, headquartered in Galway, Ireland, with offices globally. We're proud to have reached 20 million patients in over 80 countries, recognized through multiple MedTech awards and the Zenith award for Respiratory Care Excellence in North America.Our talented team collaborates to innovate,...

  • Clinical Trial Associate

    2 weeks ago

    South San Francisco, California, United States Vaxart Inc. Full time

    Job SummaryVaxart Inc. is seeking a highly skilled Clinical Trial Associate to join our team in South San Francisco. As a Clinical Trial Associate, you will provide administrative and clinical trial assistance to the Clinical Operations Department in the execution of Vaxart's clinical trials across multiple studies and various tasks.Key...

  • Clinical Trial Associate

    6 days ago

    South San Francisco, California, United States Vaxart Inc. Full time

    Job SummaryVaxart Inc. is seeking a highly skilled Clinical Trial Associate to join our team in South San Francisco. As a Clinical Trial Associate, you will provide administrative and clinical trial assistance to the Clinical Operations Department in the execution of Vaxart's clinical trials across multiple studies and various tasks.Key...

  • Senior Clinical Trial Associate

    2 months ago

    San Francisco, California, United States Meet Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will play a critical role in supporting the successful execution of clinical trials.Key ResponsibilitiesConduct site feasibility assessments and recruitment efforts, ensuring that clinical documents...

  • Senior Clinical Trial Associate

    1 month ago

    South San Francisco, California, United States Meet Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will play a critical role in supporting the successful execution of clinical trials.Key ResponsibilitiesConduct site feasibility assessments and recruitment efforts, ensuring timely and accurate...

  • Senior Clinical Trial Associate

    2 weeks ago

    South San Francisco, California, United States Meet Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Trial Associate to join our team. As a key member of our Clinical Operations team, you will play a critical role in supporting the successful execution of clinical trials.Key ResponsibilitiesConduct site feasibility assessments and recruitment efforts, ensuring the highest quality of clinical...

  • Clinical Data Analyst

    2 weeks ago

    San Francisco, California, United States Trial Library Full time

    Join Our Team as a Clinical Data AnalystWe are seeking a highly skilled Clinical Data Analyst to join our team at Trial Library, Inc. As a Clinical Data Analyst, you will play a critical role in expanding access to cancer clinical trials by supporting the development of a clinical trial matching tool and pioneering pre-screening efforts in community oncology...

  • Senior Clinical Trial Associate

    7 days ago

    South San Francisco, California, United States Structure Therapeutics Full time

    Job SummaryStructure Therapeutics is seeking a highly skilled Clinical Trial Associate to support the planning, implementation, and completion of clinical studies. The ideal candidate will have a strong background in biotechnology/pharmaceutical/clinical trial management and excellent communication and interpersonal skills.Key ResponsibilitiesObtain, review,...

  • Senior Clinical Trial Associate

    7 days ago

    South San Francisco, California, United States Structure Therapeutics Full time

    Job SummaryStructure Therapeutics is seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will play a critical role in the planning, implementation, and completion of clinical studies.Key ResponsibilitiesObtain, review, and process study-related documents, including CVs, FDA 1572s,...

  • Senior Clinical Trials Management Associate

    2 weeks ago

    South San Francisco, California, United States Planet Pharma Full time

    Job Title: Senior Clinical Trials Management AssociateJoin Planet Pharma as a Senior Clinical Trials Management Associate and contribute to the success of our clinical trials. As a key member of our team, you will be responsible for supporting all aspects of clinical trial conduct, including study start-up, enrollment, study conduct, and close-out.Key...

  • Clinical Trial Manager

    1 month ago

    South San Francisco, California, United States Abdera Therapeutics Full time

    Job Title: Sr. Study Management AssociateJob Summary:The Sr. Study Management Associate will be responsible for assisting in the oversight and management of clinical trial execution. This role will maintain oversight over CROs and key study CSPs to ensure quality conduct of trials and data collection. The Sr. Study Management Associate will work closely with...

  • Senior Clinical Trial Management Associate

    2 weeks ago

    South San Francisco, California, United States Arsenal Biosciences Full time

    Transformative Opportunities AheadJoin Arsenal Biosciences, a clinical-stage programmable cell therapy company, in our mission to defeat cancer. As a Senior Clinical Trial Management Associate, you will play a critical role in driving the future of medicine hand in hand with Technical Operations to guarantee top-tier drug quality and timely delivery.Key...

  • Clinical Research Associate Principal

    6 days ago

    San Mateo, California, United States Presidio Medical, Inc. Full time

    Job SummaryThe Principal Clinical Research Associate (CRA) is responsible for overseeing and ensuring that the rights and well-being of human subjects are protected, and that the reported trial data are accurate, complete, and verifiable from source documents. This role involves ensuring that the conduct of the trial is in compliance with the currently...

  • Clinical Research Associate Principal

    2 weeks ago

    San Mateo, California, United States Presidio Medical, Inc. Full time

    Job SummaryThe Principal Clinical Research Associate (CRA) is responsible for overseeing and ensuring that the rights and well-being of human subjects are protected, and that the reported trial data are accurate, complete, and verifiable from source documents. This role requires a strong understanding of clinical trial regulations, including ISO 14155 and...

  • Clinical Trial Specialist

    1 week ago

    San Francisco, California, United States Collabera Full time

    Clinical Trial Specialist Job DescriptionWe are seeking a detail-oriented and analytical Clinical Trial Specialist to support the development and submission of clinical trial education materials to the Promotional Review Committee (PRC).Key Responsibilities: Conduct comprehensive literature reviews to assess the landscape of new and emerging medical...

  • Clinical Operations Specialist

    2 weeks ago

    San Mateo, California, United States RICEFW Technologies, Inc. Full time

    Job Title:Sr. Clinical Trial Management Associate (Senior CTMA)Job Summary:We are seeking a highly skilled and experienced Sr. Clinical Trial Management Associate to join our Clinical Operations team in Foster City, CA. As a key member of our team, you will be responsible for managing the execution of clinical trials across all Gilead therapeutic areas.Key...

Clinical Trial Associate

3 months ago

San Mateo, United States ACL Digital Full time

Title: Clinical Trials Manager

Location: Foster City, CA Hybrid

Duration: 06+Months

Description:

FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations

POSITION OVERVIEW:

Onsite In Foster City- Hybrid

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all

Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports

global registration and commercialization of Gilead’s products.

You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members. You will manage certain

components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors. You will assist in the review of clinical study

protocols and other study documents, contribute to process development and/or participate in special projects. You may also participate in strategic initiatives.

EXAMPLE RESPONSIBILITIES:

• Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and

bioanalytical strategies in Gilead (GS) and Collaborative (CO) programs

• Participate in multiple Phase 1-4 clinical study teams

• Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial

• Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST)

• Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed

consent.

• Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure delivery

data against contracted scope of work

• Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility

• Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Vendor

Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.

• Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains

on track

• Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors

• Maintains internal Biomarker and Bioanalytical Operations databases and document repositories

• Review of relevant documents including protocols, informed consents, and relevant study documents

• Must be able to understand, interpret and explain protocol requirements to others

• Assists in determining the activities to support a project’s priorities within functional area

• Contributes to development of RFPs and participates in selection of CROs/vendors

• Able to examine functional issues from an organizational perspective

• May contribute or participate in special projects.

• Develops tools and processes that optimize project efficiencies and effectiveness.

• May contribute to development of abstracts, presentations and manuscripts

• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision

• Must have a general, functional expertise to support Process development and implementation

• Provides knowledge and expertise on country specific regulations

• Participates in and manages project meetings and conference calls with vendors and cross-functional teams.

• Develops tools and processes that optimize project efficiencies and effectiveness.

• Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.

• May be required to present at internal or external meetings (i.e., investigator meetings).

• Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support.

• Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.

• MA / MS with 3+ years’ relevant clinical or related experience in life sciences.

• BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Ability to manage any component of full cycle study management, from start-up to close-out.

• Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.

• Fully understands protocol requirements and effectively articulates and interprets these. Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.

• Familiar with standard medical / scientific terminology.

• Experience