Current jobs related to Senior Clinical Trial Associate - Menlo Park - Summit Therapeutics Sub, Inc.

  • Senior Clinical Trial Coordinator

    1 month ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job OverviewPosition Summary:The Senior Clinical Trial Associate plays a crucial role in facilitating the daily operations of clinical studies. This position involves providing essential administrative support to study teams throughout the clinical trial process. Key responsibilities include managing meeting logistics, organizing agendas, documenting meeting...

  • Senior Clinical Trial Coordinator

    1 month ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Position OverviewRole Summary:The Senior Clinical Trial Associate (Sr. CTA) plays a pivotal role in facilitating the daily operations of clinical research activities. This position entails providing comprehensive administrative assistance to study teams throughout the clinical trial lifecycle. Key responsibilities encompass managing meeting logistics,...

  • Senior Manager of Clinical Trials

    1 month ago

    Menlo Park, California, United States Summittherapeutics Full time

    Position Overview:An accomplished and self-sufficient clinical operations expert tasked with overseeing all facets of Clinical Trial Management for international studies. This role encompasses the initiation, execution, and closure of studies. You will coordinate and lead cross-functional teams, contract research organizations (CROs), and vendors to ensure...

  • Senior Clinical Trial Manager

    4 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to...

  • Clinical Trial Manager

    4 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to...

  • Senior Clinical Trial Coordinator

    4 weeks ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummarySummit Therapeutics Sub, Inc. is seeking a highly skilled Clinical Operations Specialist to support the daily workflow of clinical operations activities. The ideal candidate will provide administrative support to study teams, manage meeting logistics, and ensure accurate and timely documentation.Key ResponsibilitiesAdministrative Support: Provide...

  • Clinical Trial Manager

    1 week ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummaryWe are seeking an experienced Clinical Trial Manager to lead our global clinical operations team. The successful candidate will be responsible for managing all aspects of clinical trial management, including study start-up, maintenance, and close-out. This is a key role that requires strong leadership and collaboration skills, as well as a deep...

  • Sr. Clinical Trial Associate

    2 months ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:The CTA/Sr. CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA/Sr. CTA provides administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting...

  • Clinical Operations Associate

    3 weeks ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummarySummit Therapeutics Sub, Inc. is seeking a highly skilled Clinical Operations Associate to support the daily workflow of clinical operations activities. The ideal candidate will provide administrative support to study teams, manage meeting logistics, create agendas, and draft meeting minutes.Key ResponsibilitiesAdministrative Support: Provide...

  • Senior Manager of Clinical Data Management

    6 days ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job Title: Senior Manager, Clinical Data ManagementJob Summary:Summit Therapeutics Sub, Inc. is seeking an experienced Senior Manager of Clinical Data Management to lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology studies.Key Responsibilities:Lead and manage...

  • Clinical Trial Educator

    5 days ago

    Overland Park, Kansas, United States IQVIA Full time

    Clinical Trial Educator Job DescriptionWe are seeking a highly skilled Clinical Trial Educator to join our team at IQVIA. As a Clinical Trial Educator, you will play a critical role in providing information and education on clinical trial inclusion and exclusion criteria to trial coordinators and healthcare providers.Key Responsibilities:Provide in-service...

  • Clinical Trials Research Manager

    3 days ago

    Park Ridge, Illinois, United States Advocate Aurora Health Full time

    Job Title: Clinical Trials Research ManagerAdvocate Aurora Health is seeking a highly skilled Clinical Trials Research Manager to lead our clinical trials research team in Illinois. As a key member of our research team, you will be responsible for overseeing clinical research, including industry and federally-sponsored clinical trials, from initiation to...

  • Senior Manager, Statistical Programming Lead

    3 weeks ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummaryWe are seeking a highly experienced Senior Manager, Statistical Programming to lead our statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies.Key ResponsibilitiesLead and manage a team of statistical programmers, providing mentorship, technical...

  • Medical Director, Clinical Development Lead

    2 weeks ago

    Menlo Park, California, United States Orca Bio Full time

    Job Summary:We are seeking a Medical Director to serve as medical lead for our early-stage clinical programs, including Investigator-Sponsored Trials (ISTs) and ongoing phase 1/2 trials, across multiple disease indications. This role is critical in developing, managing, and overseeing clinical trial protocols, ensuring smooth enrollment processes, and...

  • Senior Trial Paralegal

    2 months ago

    Overland Park, United States People People Full time

    Job DescriptionJob DescriptionErise IP, a mid-sized law firm, is on a mission to find an experienced and professional Senior Trial Paralegal to join our growing, collaborative team. This position is located in Overland Park, Kansas and is an in-person position given the nature of the work to be accomplished.If you have previous mid-sized or large firm...

  • Senior Manager, Clinical Data Management

    4 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Summit is seeking an experienced, detail-oriented Sr. Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology...

  • Senior Manager, Clinical Data Management

    1 month ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Summit is seeking an experienced, detail-oriented Sr. Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology...

  • Senior Clinical Research Coordinator

    4 days ago

    Oak Park, Illinois, United States US Tech Solutions Full time

    Job Title: Senior Clinical Research CoordinatorAbout the Role:This is an exciting opportunity to join our team as a Senior Clinical Research Coordinator, where you will play a crucial role in the success of our clinical trials. As a key member of our team, you will be responsible for conducting trial visits, completing study-specific assessments, and...

  • Clinical Quality Assurance Manager

    1 month ago

    Menlo Park, California, United States Corcept Therapeutics Full time

    The Clinical Quality Assurance Manager plays a vital role within the Clinical Quality Assurance (CQA) division, overseeing daily quality operations and compliance measures to ensure the success of clinical trials managed or supported by Corcept Therapeutics.Key Responsibilities:Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical...

  • Director, Clinical Operations

    4 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:The Director will serve as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit Therapeutics. This role should demonstrate strong matrix management skills, confidence in working...

Senior Clinical Trial Associate

4 months ago

Menlo Park, United States Summit Therapeutics Sub, Inc. Full time
Job DescriptionJob Description

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

Summit Activities

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies in the following NSCLC indications:

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)

Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.

Overview of Role:

The CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA provides administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the study-specific eTMF.

Role and Responsibilities:

  • Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies
  • Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking
  • Responsible for ensuring study documentation (including trial master files (TMF), study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures.
  • Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)
  • Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
  • Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF.
  • Create and update financial information within the Ipsen financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team
  • Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US)
  • Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.
  • Check the data received from the CROs with the support of the CRM/CPM
  • Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)
  • Update the eCTMS with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable
  • Coordinate and conduct in-house and external clinical operations activities including generating contract templates within the Ipsen dedicated system (i-CAP), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts
  • Attend all study team meeting when appropriate and take meeting minutes
  • Perform any clinical study activity delegated by CRM/CPM such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors
  • Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes

Experience, Education and Specialized Knowledge and Skills:

  • 2+ Years of Experience in clinical study environment within CRO or Pharmaceutical company.
  • Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out.
  • Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines
  • Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.
  • Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment.
  • Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.
  • Attention to detail, accuracy and confidentiality.
  • Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
  • Work in a fast-paced, demanding and collaborative environment.
  • Demonstrate high ethical standards for honesty, truthfulness and integrity.

The pay range for this role is $108,336 to $120,242 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.