Clinical Trials Manager

11 hours ago

Foster City, United States Fusion Life Sciences Technologies LLC Full time

Clinical Trials Manager
Job Location: Foster City, CA
Job Duration: 6 months
visa Green Cards and USA citizens

manager is looking for local candidates

POSITION OVERVIEW:
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas.
Clinical Operations play 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.
• Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development

Job Description – Clinical Trial Manager (CTM)
• 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.
• Travel may be required

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.
• Meets all requirements for Senior Clinical Trial Management Associate (Senior CTMA) grade 26 position with demonstrable proficiency.
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 managing the work of external vendors.
• Ability to communicate in a clear and concise manner.
• Ability to support a team-oriented, highly-matrixed environment.
Ability to execute multiple tasks as assigned.
• When needed, ability to travel.

  • Clinical Trial Manager

    1 month ago

    Redwood City, United States Advanced Clinical Full time

    About the Company: We are seeking a Clinical Trial Manager/Senior Clinical Trial Manager for an oncology pharma in the Bay Area. This role requires experience managing phase I-III global Oncology studies. Please note, this role is HYBRID and CANNOT ACCOMMODATE REMOTE Employees at this time. As a CTM/Senior CTM, you will work within GCP and FDA regulatory...

  • Clinical Trial Manager

    5 days ago

    Foster City, United States ACL Digital Full time

    Title: Clinical Trial Manager Location: Foster City, CA (100% onsite)Duration: 06-12 months Responsibilities: Collaborating with Project Manager to set targets for clinical monitoring staff, and ensuring the recording of trial in compliance with project goals.Creating and implementing study-specific clinical monitoring tools and documents.Creating and...

  • Clinical Trials Manager

    4 weeks ago

    Foster City, California, United States Collabera Full time

    Clinical Trials Manager Job DescriptionCollabera is seeking a highly skilled Clinical Trials Manager to join our team. As a Clinical Trials Manager, you will be responsible for the worldwide execution of all Phase I - IV clinical trials across all our therapeutic areas. You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical...

  • Clinical Trial Manager

    2 days ago

    Foster City, United States LeadStack Inc. Full time

    Job Title: Clinical Trials Manager - I*Location: Foster City, CADuration: 6 monthsPR: $75/hr - $85/hr on W2 Description:Position overview:Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations play a key role in ensuring all clinical trials are performed in...

  • Clinical Operations Manager/Clinical Trials Manager

    2 days ago

    Foster City, United States Infotree Global Solutions Full time

    One of our leading Pharmaceutical client is looking for a Clinical Operations Manager/Clinical Trials Manager , who is responsible for the worldwide execution of all Phase I - IV clinical trials across all Company therapeutic areas. Also manage biomarker and bioanalytical vendors.Job Title: Clinical Operations Manager/Clinical Trials ManagerW2 Contract &...

  • Clinical Trial Manager

    5 days ago

    Foster City, United States RICEFW Technologies Inc Full time

    Clinical Trial Manager FUNCTION: Clinical Operations – Biomarker and Bioanalytical OperationsFoster City- Hybrid (2-3 days a week onsite)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 allGilead clinical trials are...

  • Clinical Trials Management Associate

    3 days ago

    Foster City, United States ATR International Full time

    Job DescriptionJob DescriptionWe are seeking a Clinical Trials Management Associate - II for a very important client.(Candidate must be local to Foster City, CA)Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all client therapeutic areas. Clinical Operations plays a key role in ensuring all client...

  • Clinical Trial Manager

    5 days ago

    Foster City, United States LeadStack Inc. Full time

    Job Title: Clinical Trial ManagerLocation: Foster City- HybridDuration: 6 monthsPR: $70/hr - $80/hr Description:FUNCTION: Clinical Operations – Biomarker and Bioanalytical OperationsClinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all client therapeutic areas.Clinical Operations plays a key role in...

  • Clinical Trial Manager

    2 days ago

    Foster City, United States Fladger Associates Full time

    EXAMPLE RESPONSIBILITIES:• Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker andbioanalytical strategies in Gilead (GS) and Collaborative (CO) programs• Participate in multiple Phase 1-4 clinical study teams• Plans and coordinates all operational...

  • Clinical trial Manager

    5 days ago

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

    Title- Clinical trial Manager-ILocation- Foster City,CADuration- 6 months ( possible extension)5 days oniste roleJob Description:FUNCTION: Clinical Operations – Biomarker and Bioanalytical OperationsPOSITION OVERVIEW:Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Client therapeutic areas....

  • Clinical Trial Manager

    5 days ago

    Redwood City, United States Meet Full time

    🚀 Our Client is Hiring: Clinical Trial Manager (CTM) – Oncology Experience 🚀Are you passionate about oncology research and clinical trials? Our client, a leading biotech company focused on developing innovative cancer therapies, is seeking a talented Clinical Trial Manager (CTM) to join their team in Redwood City, CA.As a Clinical Trial Manager, you...

  • Clinical Trial Assistant

    2 months ago

    Foster City, United States ATR International Full time

    Job DescriptionJob DescriptionJob Title: Clinical Trials Project Assistant IIType: Contract - 6 MonthsPay: $46.00/hrLocation: 333 Lakeside Drive, Foster City, CAFUNCTION: Clinical Operations – Biomarker and Bioanalytical OperationsPOSITION OVERVIEW:Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all...

  • Clinical Trial Manager

    3 weeks ago

    Redwood City, United States Meet Full time

    Clinical Trial Manager - SF Bay Area OncologyJoin a rapidly growing biotech company focused in oncology research. This company fosters a highly collaborative environment, as well as allowing for high levels of professional growth. The team is looking for an experienced Clinical Trial Manager to lead their clinical trials. This is a high-visibility role where...

  • Clinical Trials Manager

    3 weeks ago

    Union City, United States XII Medical Full time

    Company Summary: XII Medical is an innovative medical device company working on developing a next generation neurostimulation system for treating obstructive sleep apnea. The next-generation system aims to increase patient compliance by reducing surgical invasiveness and improving the patient’s sleeping habits.Job Summary: The Clinical Trial Manager (CTM)...

  • Clinical Trial Manager

    4 weeks ago

    Redwood City, California, United States Guardant Health Full time

    Job SummaryGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through the use of its proprietary tests, vast data sets, and advanced analytics.The company's oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes, and lower healthcare costs across all stages of...

  • Clinical Trial Operations Manager

    4 weeks ago

    Redwood City, California, United States Adverum Biotechnologies, Inc. Full time

    About the Role:Adverum Biotechnologies, Inc. is seeking a highly skilled Clinical Trial Operations Manager to join our team. As a key member of our clinical operations team, you will be responsible for managing and providing daily operational oversight of Contract Research Organizations (CROs), study vendors, and clinical trial sites. Your primary goal will...

  • Senior Clinical Trial Manager, Clinical Operations

    4 weeks ago

    Redwood City, California, United States Coherus BioSciences Full time

    Clinical Operations Senior Manager, Clinical TrialThis position will work with the Coherus clinical team to manage the execution of clinical studies for Coherus' various products. Depending on project complexity and level of experience, this may include managing one or more clinical studies and/or managing a multi-national region for multiple global clinical...

  • Clinical Trial Associate, Study Management

    3 weeks ago

    Jersey City, United States Spectraforce Technologies Full time

    Clinical Trial Associate, Study Management23 months RemoteEducation / Certificates: * Bachelor's degree in Life Sciences with minimum 3 or MS in Life Sciences with minimum 1+ year of relevant experience in clinical drug development.Experience * Practical experience working with of Service Providers/vendors for trial conduct * Good level navigation skills in...

  • Clinical Trials Assistant Director

    4 weeks ago

    Oklahoma City, Oklahoma, United States The University of Oklahoma Full time

    As a key member of The University of Oklahoma, the Clinical Trials Assistant Director plays a pivotal role in overseeing the administration and operational aspects of clinical trials. This includes information management, budgeting, process improvement, business planning, and regulatory compliance.Key Responsibilities:Develop and implement informatics...

  • Clinical Trial Associate

    4 weeks ago

    Jersey City, United States Yoh, A Day & Zimmermann Company Full time

    Job DescriptionJob DescriptionYoh Scientific is actively recruiting for a fully remote, Clinical Trial Associate to work a long-term contract assignment.  If interested and qualified, please apply for immediate consideration!      Title: Clinical Trial AssociateLocation: Fully Remote (EST or CST location preferred, due to business hours)Work Schedule:...