Jobs
>
San Francisco

    Senior Manager, Clinical Trial Lead - San Francisco, United States - Olema Pharmaceuticals

    Olema Pharmaceuticals
    Olema Pharmaceuticals San Francisco, United States

    4 days ago

    Default job background
    Description
    About the Role >>> Senior Manager, Clinical Trial Lead

    We are looking for a Senior Manager, Clinical Trial Lead (CTL) for our growing Clinical Operations team.

    The Senior Manager, Clinical Trial Lead is responsible for the day-to-day management of clinical trials, vendors, and clinical trial sites.

    This position will work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, timelines, and budgets.

    We are looking for a capable trial manager with the ability to perform and manage the duties and functions necessary to deliver a quality study on time and within budget.


    This is a fantastic opportunity for a hands-on Clinical Trial Lead to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women's oncology company with significant potential to transform breast cancer treatments.


    Your work will primarily encompass:

    • Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trial
    • Lead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study team
    • Support delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
    • Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
    • Assist in preparation and review of clinical trial documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documents
    • Triage CRO and clinical site questions
    • Facilitate cross-functional study team meetings and/or delegate to a Sr./CRA, as appropriate; liaise with other cross-functional areas for oversight of clinical study activities.
    • Partner with eTMF team to ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
    • Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation
    • Responsible for and participates in service provider selection process as a part of outsourcing activities
    • Proactively identify and resolve clinical project issues and participates in process improvement initiatives as required
    • Responsible for assessing operational feasibility, recommending study execution plan, and site selection
    • Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
    • In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
    • Support oversight of clinical trial budgets, providing ongoing financial reporting and projections
    • Negotiate and finalize site contracts and budgets
    • Perform and manage data review process on an ongoing basis
    • Oversight of site visits including site qualification, initiation, monitoring, and close-out visits, as needed
    • Oversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues
    • Ensure tracking and review of protocol deviations and assess impact on study data
    • Review and approve clinical invoices against the approve scope of work for clinical vendors
    • Provide oversight for forecasting of clinical supplies, including study drug and supplies
    • Manage / oversee work of, as well as mentor, junior Clinical Operations staff; may have direct reports
    • Support development and review of Clinical SOPs and other department initiatives
    • Travel as needed to sites, conferences, and industry meetings
    • Other duties as may be assigned
    Ideal Candidate Profile >>>

    A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives.

    All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture.

    As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.


    Knowledge:

    • Bachelor's Degree is required, advanced degree is preferred
    • 8+ years of clinical research experience and 3+ years of clinical trial management experience leading clinical trials within the biotech or similar industry
    • Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
    • Strong clinical project manager skills
    • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met
    • Excellent communication skills to effectively disseminate information to project team and outside parties

    Experience:

    • Global and Phase 1-3 trial experience is required
    • Oncology experience is required, breast cancer experience is preferred
    • Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
    • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
    • Experience managing/overseeing CROs/vendors and scopes of work
    • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
    • Working knowledge of MS Project for development and update of clinical study timelines
    • Experience managing CROs and other clinical vendors

    Attributes:

    • Excellent organizational, conflict resolution, prioritization and negotiation skills
    • Excellent verbal and written communication and skills
    • Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
    • Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
    • Commitment to excellence
    • Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
    • Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others


    The base pay range for this position is expected to be $175,000 - $190,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.

    The total compensation package for this position also includes equity, bonus, and benefits.

    #LI-CK1
  • Neurona Therapeutics

    Clinical Trial Lead

    3 weeks ago

    Neurona Therapeutics South San Francisco, United States

    CLINICAL TRIAL LEAD - U.S. BASED REMOTE OPPORTUNITY POSITION · Neurona Therapeutics is an early-stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated ...

  • IQVIA

    Solution Specialist

    1 week ago

    IQVIA San Francisco, United States Full time

    Job Overview · The Solution Specialist will ultimately become a Subject Matter Expert in the domain of Medical Devices and our eSource Platform' s role in clinical trials; providing customer support to site and Sponsors. · The focus will be on the implementation and ongoing supp ...

  • Avata Partners

    Associate Attorney

    4 weeks ago

    Avata Partners San Francisco, United States

    If you are looking for a fast career progression and being part of a collaborative team, then this is the position for you · A well-known and leading law firm in San Francisco is seeking an experienced Attorney to join their dynamic practice, handling complex litigation matters. ...

  • Avata Partners

    Associate Attorney

    4 weeks ago

    Avata Partners San Francisco, United States

    Our client is seeking a mid-level Associate to join their SF Litigation Group. The ideal candidate will have 3-6 years of commercial litigation experience. The candidate must have a strong desire to continue development of trial and litigation skills and ultimately the ability an ...

  • Snappyhires

    Senior Litigation Attorney

    2 weeks ago

    Snappyhires San Francisco, United States

    Job Description:- · In this Senior Litigation Associate role, you will provide legal advice and guidance to our clients, work closely with our team of attorneys and support staff, and take a leadership role in developing litigation strategies. · What You'll Bring to the Table: · ...

  • IQVIA

    Clinical FSP Laboratory Vendor Manager

    1 day ago

    IQVIA San Francisco, United States Full time

    IQVIA's Sponsor Delivery Unit is a global team of professionals dedicated to partnering with our client to drive healthcare forward and to enable medical breakthroughs that advance healthcare and patient treatment options around the world. This sponsor dedicated unit is working w ...

  • AGG Legal Staffing

    Senior Associate Attorney

    1 week ago

    AGG Legal Staffing San Francisco, United States

    Seeking a California licensed Senior Associate Litigation Attorney with 5 to 7 years of experience for a boutique law firm specializing in toxic tort and asbestos litigation to join the trial team covering all aspects of litigation and to be a team leader to junior associates. · ...

  • Meet

    Senior Accountant

    3 weeks ago

    Meet San Francisco, United States

    Attention to details, organization, and good analytical skills are essential to this roleMinimum 5 years' experience in General Accounting or financial auditExperience in monthly close activities or financial audit in a deadline-driven environmentERP systems experience, bonus poi ...

  • State of California

    staff services manager i

    2 weeks ago

    State of California San Francisco, United States

    Job Posting: eDLS Project Manager · Department of Justice · JC eDLS Project Manager · STAFF SERVICES MANAGER I $6, $8,398.00 per Month · Final Filing Date: 6/6/2024 · Application Methods: Electronic (Using your CalCareer Account) By Mail Drop-off Job Description and Duti ...

  • Intelliswift Software

    Product Marketing Manager

    3 weeks ago

    Intelliswift Software San Francisco, United States

    Job Title - Product Marketing Manager · Client Location - San Francisco, CA (Flexible to work remote / occasional visit to the office as basis needed) · Duration - 06 months contract with possible extension · Product marketing -- messaging & positioning, strong narrative writing, ...

  • MasterControl

    Financial Analyst

    5 days ago

    MasterControl West Valley City, United States

    About MasterControl · MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterContr ...

  • InsideHigherEd

    Instructor Pool

    1 week ago

    InsideHigherEd San Francisco, United States Faculty Jobs ,

    · Instructor Pool - Clinical Research, Regulatory Affairs, and Biotechnology - UC Berkeley Extension · Position overview · Salary range: A reasonable estimate for this position is $1,400-$5,000 per course, or $200-$375/student for an asynchronous online course. Instructor compe ...

  • We Are Legal Revolution

    Land Use/Environmental Partner

    3 weeks ago

    We Are Legal Revolution San Francisco, United States

    Land Use/Environmental Partner/Of Counsel · California, San Francisco · Salary up to $350k · In the more than four decades since its founding, the firm has developed a reputation as one of California's leading mid-size law firms. · They offer an extensive complement of legal serv ...

  • State of California

    coastal program analyst iii

    2 weeks ago

    State of California San Francisco, United States

    Job Posting: Principal Enforcement Analyst · San Francisco Bay Conservation & Development Commission · JC Principal Enforcement Analyst · COASTAL PROGRAM ANALYST III $7, $9,084.00 per Month · Final Filing Date: Until Filled · Application Methods: Electronic (Using your Cal ...

  • City and County of San Francisco

    Paralegal- Trial/Litigation Team- City Attorney's Office

    1 week ago

    City and County of San Francisco San Francisco, United States Full time

    Job Description · About the Litigation Team · The Litigation Team is a collaborative and dynamic group of 23 attorneys, seven paralegals and legal assistants, and seven legal secretaries. The Team defends litigation filed against the City and County of San Francisco in State and ...

  • snaphire

    Accounting Operations, Senior Manager 89bio

    3 weeks ago

    snaphire San Francisco, United States

    89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glyc ...

  • State of California

    Supervising Analyst

    3 weeks ago

    State of California San Francisco, United States

    Job Posting: Supervising Analyst JO#6234 · Judicial Council of California · JC Supervising Analyst JO#6234 · Supervising Analyst $8, $12,033.00 per Month · Final Filing Date: 6/18/2024 · Application Methods: By Mail Job Description and Duties · RESPONSIBILITIES · Manag ...

  • 89bio

    Accounting Operations, Senior Manager

    3 weeks ago

    89bio San Francisco, United States

    THE COMPANY89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engi ...

  • Sentry

    Sales Engineer

    2 days ago

    Sentry San Francisco, United States

    About Sentry · Bad software is everywhere, and we're tired of it. Sentry is on a mission to help developers write better software faster, so we can get back to enjoying technology. · With more than $217 million in funding and 100,000+ organizations that believe we're on to some ...

  • Adobe

    Staff Growth Experience Designer, Monetization and B2B

    3 days ago

    Adobe San Francisco, United States Full time

    Our Company · Changing the world through digital experiences is what Adobe's all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences We're passionate about empowering people to create beautiful ...