Clinical Trial Manager

2 weeks ago

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

Overview 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 successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

  • Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
  • Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
  • Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
  • Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
  • Proactive identification and management of study related risks
  • Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
  • Responsible for reviewing and managing study related plans, processes including
  • Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
  • Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
  • Reviews and approves essential document packages to enable timely site activations
  • Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
  • Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
  • Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
  • Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
  • Perform periodic QC of the TMF
  • Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
  • Ensures the study is “inspection ready” always
  • Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
  • All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

  • Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
  • 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
  • Prior phase II and III experience required
  • A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
  • Experience with budget forecasting and management
  • Experience with clinical studies in oncology
  • Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
  • Proven proficiency in overseeing large complex studies being managed in house and by a CRO
  • Demonstrated ability to lead teams and work in a fast-paced team environment
  • Experienced and enjoys building relationships with KOLs and site personnel
  • Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
  • Demonstrated ability to build and deliver on patient enrollment strategies
  • Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
  • Demonstrated ability to comprehend complex scientific concepts and data
  • Proficient in reviewing and assessing clinical data
  • Possesses excellent planning, time management & coordination skills
  • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
  • Experience in working in a small organization
  • Excellent written and oral communication skills

The pay range for this role is $135,000 to $155,000 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.

  • Senior Manager of Clinical Trials

    2 weeks 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

    2 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

    2 weeks 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

    2 weeks 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 Clinical Trial Coordinator

    7 days 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...

  • Sr. Clinical Trial Associate

    1 month 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 Quality Assurance Manager

    2 weeks 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...

  • Senior Manager, Clinical Data Management

    1 week 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

    3 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...

  • Clinical Study Manager

    7 days 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 Assistant

    4 weeks ago

    Overland Park, Kansas, United States IQVIA Full time

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

  • Clinical Quality Assurance Manager

    2 weeks 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) team, overseeing daily quality operations and compliance measures to ensure the effective execution of clinical trials supported by Corcept Therapeutics.Key Responsibilities:Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical...

  • Director, Clinical Operations

    7 days 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...

  • Clinical Quality Assurance Manager

    2 weeks ago

    Menlo Park, California, United States Corcept Therapeutics Full time

    The Manager of Clinical Quality Assurance (CQA) plays a vital role within the CQA team, overseeing daily clinical quality operations and compliance tasks essential for the successful execution of clinical trials supported by Corcept Therapeutics.Key Responsibilities:Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical...

  • Manager, Clinical Site Operations RWE Clinical Trials- Overland Park

    3 weeks ago

    Overland Park, United States Walgreens Full time

    Job Description Job Summary The Manager, Clinical Site Operations reports to the Director, Clinical Site Operations, and functions as the direct manager for patient-facing site staff supporting assigned studies. This role supervises clinical trial activities, the implementation of and adherence to study protocols, and oversees the schedules of...

  • Associate Director Clinical Operations

    4 weeks ago

    Menlo Park, United States The Steely Group Full time

    M-F standard hours with OT - this is a true startupOnsite in Menlo Park, CAAssociate Director/Director, Clinical OperationsJob OverviewWe are looking for a talented and highly motivated Clinical Operations professional to join our client's fast-paced biotech startup. Under the direction of the Executive Director, Clinical Operations, this role will support...

  • Clinical Operations Associate

    4 days 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...

  • Sr. Manager, Statistical Programming

    3 weeks ago

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

    Job DescriptionJob DescriptionOverview of Role:The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of...

  • Senior Manager, Statistical Programming Lead

    4 days 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...

  • Clinical Trial Lab Technician

    2 weeks ago

    Highland Park, United States SQRL Full time

    HighlightsStepping stone into Clinical Research!Great benefits including 401k with matchM - F Schedule, no weekends or holidays!Meaningful work to play a part in drug researchThe CompanyOur client is a fast growing site network that currently has over 20 sites and constantly expanding! They focus on diversity in their trials including therapeutic areas:...