Clinical Operations Manager

2 weeks ago

California, United States Bayside Solutions Full time
Clinical Trial Manager Job Summary

This is a unique opportunity for an experienced Clinical Operations Professional with technical expertise in managing Phase I-III clinical trials in an industry setting and who has a strong knowledge of clinical operations, Good Clinical Practice (GCP), and US Food and Drug Administration (FDA) regulatory requirements.

Key Responsibilities:

  • Perform clinical operations functional activities related to the execution of assigned clinical trials based on department and corporate goals and objectives.
  • Manage clinical studies and vendors to ensure studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and International Council for Harmonization (ICH)/ GCP guidelines.
  • Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) providers, and independent contractors) to execute clinical trials.
  • Review and contribute to developing study-specific documentation, including clinical trial protocols, case report forms, study guides/manuals, informed consent forms, and clinical databases.
  • Review monitoring reports and other study documentation as required.
  • Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
  • Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
  • Follow up on assigned team action items and identify, escalate, and resolve issues as needed.
  • Collaborate with contract specialists to review and negotiate clinical trial agreements and site-specific study budgets.
  • Assess the adequacy and feasibility of potential clinical investigators and sites, including evaluating facilities, personnel, patient referral base, and adherence to GCP.
  • Develop clinical study monitoring priorities and Monitoring Plan in conjunction with CRO.
  • Conduct site visits (e.g., training visits, site initiation visits, monitoring visits) as required.
  • Manage investigational product accountability and the reconciliation process.
  • Assist with preparing safety, interim, and final clinical study reports and resolving data discrepancies.
  • Provide clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
  • Prepare and track study participant enrollment projections vs. actuals and study budgets.
  • Serve as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.

Requirements and Qualifications:

  • BS or MS degree with a minimum of 5+ years of clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in Oncology drug development
  • Hands-on experience in running early-stage clinical trials within an industry environment
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Experience in the selection of CROs and vendors and management of external resources.
  • A demonstrable record of solid vendor management and teamwork
  • Direct experience in managing clinical CROs
  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  • Excellent written and verbal communication skills
  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is crucial.
  • Able to travel (~25%)
  • Oncology experience is preferred.
  • Experience in working with cooperative group studies and investigator-sponsored trials is preferred.
  • Experience in global clinical trial operations is a plus.
  • Knowledge of APAC regulations is highly desired.

Desired Skills and Experience:

Clinical trial, Phase I-III, drug development, Oncology, GCP, FDA, ICH, vendor management, travel, APAC

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy

  • Clinical Quality Assurance Manager

    3 weeks ago

    California, United States Advanced Clinical Full time

    Job Title: Clinical Quality Assurance ManagerWe are seeking a highly skilled Clinical Quality Assurance Manager to join our team at Advanced Clinical. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our clinical research operations.Key Responsibilities:Develop and implement quality...

  • Clinical Quality Assurance Manager

    4 weeks ago

    California, United States Advanced Clinical Full time

    Job SummaryWe are seeking a highly skilled Clinical Quality Assurance Manager to join our team at Advanced Clinical. As a key member of our organization, you will be responsible for ensuring the highest level of quality and compliance in our clinical studies.Key ResponsibilitiesAudit Strategy Development: Identify and prioritize audit strategies for GCP...

  • Clinical Quality Assurance Manager

    2 weeks ago

    California, United States Advanced Clinical Full time

    Job Title: Clinical Quality Assurance ManagerWe are seeking a highly skilled Clinical Quality Assurance Manager to join our team at Advanced Clinical. As a Clinical Quality Assurance Manager, you will be responsible for ensuring the quality and integrity of our clinical studies.Key Responsibilities:Develop and implement quality assurance strategies to ensure...

  • Clinical Trial Operations Manager

    4 weeks ago

    California, United States Innova Solutions Full time

    Job Summary:Innova Solutions is seeking a highly skilled Clinical Trial Operations Manager to join our team. As a Clinical Trial Operations Manager, you will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites.Key...

  • Clinical Trial Operations Manager

    4 weeks ago

    California, United States Hamlyn Williams Full time

    About the RoleHamlyn Williams is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will play a critical role in the development and commercialization of innovative biotherapeutics.Key ResponsibilitiesStudy Management: Support and coordinate clinical trial activities, manage execution of 1 or more clinical...

  • Clinical Operations Manager

    4 weeks ago

    Redwood City, California, United States CommonSpirit Health Full time

    Job SummaryWe are seeking a highly skilled and experienced Clinical Operations Manager to join our team at CommonSpirit Health. As a Clinical Operations Manager, you will be responsible for overseeing the day-to-day operations of our outpatient clinic, ensuring the smooth flow of patient care and staff management.Key ResponsibilitiesOversee the management of...

  • Clinical Operations Director

    7 days ago

    California, United States Meet Full time

    Director Clinical Operations Job DescriptionMeet is seeking a highly experienced Director Clinical Operations to lead the successful execution of clinical trials and programs. As a key member of the clinical operations team, you will be responsible for providing operational leadership and management for multiple clinical studies, including the direct...

  • Clinical Operations Director

    4 weeks ago

    California, United States Meet Full time

    Job SummaryWe are seeking a highly experienced Clinical Operations Director to lead our clinical trials team. The ideal candidate will have a strong background in managing complex clinical trials, with a focus on autoimmune and oncology indications.Key ResponsibilitiesOperational Leadership: Provide strategic direction and oversight to the clinical trials...

  • Clinical Operations Specialist

    3 weeks ago

    California, United States Bayside Solutions Full time

    Clinical Trial ManagerJob Summary:This is an exciting opportunity for an experienced Clinical Operations Professional to join our team at Bayside Solutions, Inc. As a Clinical Trial Manager, you will be responsible for overseeing Contract Research Organizations (CROs) and ensuring the successful execution of our clinical studies. If you have a strong...

  • Senior Clinical Trial Operations Manager

    1 month ago

    California, United States Meet Full time

    Meet the challenges of a dynamic and innovative biopharmaceutical company as a seasoned clinical trial professional. We are dedicated to transforming lives through groundbreaking therapies.Key Responsibilities:Oversee the planning, implementation, and management of clinical trials from start to finish, ensuring seamless execution and timely delivery.Develop...

  • Clinical Team Manager

    3 weeks ago

    California, United States North York General Hospital Full time

    Job Title: Clinical Team Manager - Peri-Operative ServicesNorth York General Hospital is seeking a highly skilled and experienced Clinical Team Manager to lead our Peri-Operative Services team. As a key member of our leadership team, you will be responsible for ensuring operational and clinical excellence, while facilitating the provision of an outstanding...

  • Director of Clinical Operations

    4 weeks ago

    California, United States Net2Source Inc. Full time

    Job Description:**Job Summary:**We are seeking a highly experienced and skilled Associate Director of Quality Assurance to join our team at Net2Source Inc. as a key member of our Clinical Operations department.Key Responsibilities:Develop, optimize, and implement clinical trial processes across the organization, ensuring compliance with regulatory...

  • Clinical Operations Director

    4 weeks ago

    California, United States Discover International Full time

    Director/Senior Director, Clinical OperationsDiscover International is seeking an experienced and skilled Director/Senior Director of Clinical Operations to lead our late-phase clinical trials. This critical role will play a key part in advancing our innovative pipeline.Key Responsibilities:Oversee the execution of late-phase clinical trials, ensuring...

  • Clinical Operations Manager

    3 weeks ago

    Mountain View, California, United States BetterHelp Full time

    About the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at BetterHelp. As a key member of our Clinical Operations Team, you will play a critical role in ensuring the quality and efficiency of our clinical services.Key ResponsibilitiesProvide support to our counselor network via email, phone, and chat to ensure they have the...

  • Clinical Trial Operations Specialist

    4 weeks ago

    California, United States Bayside Solutions Full time

    {"Job Title": "Clinical Trial Manager", "Job Summary": "Are you a seasoned Clinical Operations Professional looking for a new challenge?This role offers a unique opportunity to oversee Contract Research Organizations (CROs) and ensure the successful execution of our clinical studies.We are seeking an experienced professional with technical expertise in...

  • Senior Director of Clinical Operations

    2 weeks ago

    California, United States Discover International Full time

    Job Title: Director/Senior Director, Clinical OperationsLocation: Onsite in CaliforniaJob Overview:We are seeking an experienced and motivated Director/Senior Director of Clinical Operations to oversee our late-phase clinical trials. This role is critical to advancing our exciting and innovative pipeline. The ideal candidate will have substantial experience...

  • Medical Director

    4 weeks ago

    California, Missouri, United States NurseRecruiter, LLC Full time

    Job SummaryWe are seeking a highly skilled and experienced Medical Director to lead our clinic operations. As a key member of our team, you will be responsible for managing patient care and clinical operations, implementing clinical model playbooks, and ensuring accurate records and billing.Key ResponsibilitiesManage Patient Care and Clinical Operations:...

  • Clinical Trial Manager

    4 weeks ago

    California, United States Innova Solutions Full time

    {"title": "Clinical Trial Manager", "description": "Job SummaryInnova Solutions is seeking a highly skilled Clinical Trial Manager to oversee the day-to-day operations of global clinical trials. This role will manage internal stakeholders, CROs, service providers, clinical monitors, and trial sites to ensure timely and compliant study execution.Key...

  • Clinical Trials Operations Manager

    3 weeks ago

    South San Francisco, California, United States Biogen Full time

    About This OpportunityMake a meaningful impact in your career with Biogen, a leading biotechnology company. As a Clinical Trial Manager, you will design and oversee the operational strategy for clinical research studies, working closely with our partners to deliver high-quality results.Key ResponsibilitiesDevelop and implement study-level operational...

  • Telemetry Department Clinical Operations Manager

    1 month ago

    California, USA, United States Desert Regional Medical Center Full time

    Job SummaryDesert Regional Medical Center is a leading healthcare provider in the region, classified as a stroke receiving center and level 2 trauma facility. We are seeking a highly skilled and experienced Clinical Unit Manager to lead our Telemetry Department.Key ResponsibilitiesProvide strategic leadership and direction to the Telemetry Department,...