Clinical Trials Manager

1 day ago

Foster City, United States Planet Pharma Full time

Job Title: Clinical Trial Manager (CTM)

Location: Foster City, CA

Contract Duration: 6 months

Pay Rate: $83/hr.

Top 6 Skills:

  1. Capable of managing full-cycle study management, from start-up to close-out.
  2. Advanced knowledge of study management best practices, tools, and techniques to improve study efficiency.
  3. Strong understanding of protocol requirements and ability to interpret and communicate them effectively.
  4. Thorough knowledge of FDA, EMA, ICH guidelines, and GCP governing clinical trials.
  5. Familiarity with medical and scientific terminology.
  6. Experience managing external vendors.


Position Overview:

Clinical Operations is responsible for the global execution of Phase I-IV clinical trials across all therapeutic areas. The Clinical Operations team ensures that clinical trials are conducted in compliance with SOPs, company policies, and regulatory guidelines, delivering high-quality clinical data that supports global product registration and commercialization.

As a Clinical Trial Manager (CTM), you will collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology, and other cross-functional teams. Your role will involve managing specific components of clinical studies, overseeing biomarker and bioanalytical vendors, reviewing study protocols, and contributing to process development. You may also participate in strategic initiatives and special projects.


Key Responsibilities:

  • Serve as the primary operational contact for biomarker and bioanalytical strategies in clinical programs, liaising with internal and external stakeholders.
  • Participate in multiple Phase 1-4 clinical study teams.
  • Plan and coordinate operational activities for the collection, delivery, and analysis of biological specimens within clinical trials.
  • Provide sample management expertise to Study Management Teams (SMTs), Biomarker Subteams (BSTs), and Clinical Pharmacology Subteams (CPSTs).
  • Ensure the collection of high-quality biological samples, adhering to the highest standards of ethics and informed consent.
  • Act as the main point of contact for operational activities between the SMT and laboratory vendors, managing vendor operations and ensuring data delivery per contracted scope.
  • Evaluate scientific proposals, protocols, and clinical feasibility, including budget considerations for clinical operations.
  • Build strong cross-functional relationships with Biomarker Sciences, Vendor Outsourcing, Clinical Operations, and Data Management teams to ensure efficient biomarker strategy execution.
  • Identify and resolve potential operational challenges, working with senior team members to ensure biomarker strategies stay on track.
  • Lead operational meetings with study functional groups or vendors.
  • Maintain internal databases and document repositories for Biomarker and Bioanalytical Operations.
  • Review relevant study documents, including protocols, informed consents, and study plans.
  • Assist in determining priorities and activities within the functional area to support project objectives.
  • Contribute to RFP development and vendor/CRO selection.
  • Participate in strategic initiatives and special projects.
  • Develop tools and processes that improve project efficiency and effectiveness.
  • May assist in recruiting and developing talent within the Clinical Trial Management team.
  • Contribute to abstracts, presentations, and manuscripts.
  • Manage project meetings and conference calls with vendors and cross-functional teams.
  • Assist in preparing study reports and resolving data discrepancies, particularly for biomarker data related to primary or secondary endpoints.
  • Ensure compliance with established practices, policies, and regulatory requirements.
  • Travel may be required.


Qualifications:

Education and Experience:

  • PharmD/PhD with 2+ years of relevant clinical or life sciences experience.
  • MA/MS with 3+ years of relevant clinical or life sciences experience.
  • BA/BS/RN with 5+ years of relevant clinical or life sciences experience.
  • Must meet qualifications for Senior Clinical Trial Management Associate (Senior CTMA) grade 26, with demonstrated proficiency.


Knowledge and Skills:

  1. Quick learner with the ability to adapt to changing project needs.
  2. Capable of managing full-cycle study management, from start-up to close-out.
  3. Advanced knowledge of study management best practices, tools, and techniques to improve study efficiency.
  4. Strong understanding of protocol requirements and ability to interpret and communicate them effectively.
  5. Thorough knowledge of FDA, EMA, ICH guidelines, and GCP governing clinical trials.
  6. Familiarity with medical and scientific terminology.
  7. Experience managing external vendors.
  8. Excellent communication skills, both written and verbal.
  9. Ability to thrive in a team-oriented, matrixed environment and manage multiple tasks simultaneously.
  10. Willingness to travel when necessary.

  • Clinical Trial Manager

    2 months 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

    1 week 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 days 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...

  • Clinical Trial Manager

    5 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 Trial Manager

    2 days ago

    Foster City, United States SPECTRAFORCE Full time

    Title: Clinical Trials ManagerDuration: 06 MonthsLocation: Foster City, CADescription: 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 accordance with applicable SOPs, company policies and...

  • Clinical Operations Manager/Clinical Trials Manager

    5 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

    1 week 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

    7 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 Trials Management Associate

    2 days ago

    Foster City, United States Fladger Associates Full time

    Responsibilities:Excellent employment opportunity for a Clinical Trials Management Associate - II in the Foster City, CA area.Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all company therapeutic areas.Clinical Operations plays a key role in ensuring all the Company clinical trials are performed in...

  • Clinical Trial Manager

    1 week 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

    5 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 Trials Manager I

    2 days ago

    Foster City, United States Planet Pharma Full time

    **CANDIDATES REQUIRING RELOCATION WILL NOT BE CONSIDERED**6 Month Contract (May extend or convert to permanent)$83/hour W2POSITION 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 trial Manager

    1 week 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....

  • Senior Clinical Trial Specialist

    2 days ago

    Foster City, United States Intelliswift Software Full time

    Job Details: Position Title: Clinical Operations – Biomarker and Bioanalytical Operations Location: Foster City, CA. Duration: 06 Months Contract on w2 POSITION OVERVIEW: Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all *** therapeutic areas. Clinical Operations plays a key role in ensuring all...

  • Clinical Trial Manager

    1 week 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 Operations Manager

    1 month 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...

  • Clinical Trial Associate, Study Management

    4 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...