- Assist with third-party vendor training on protocols and practices. Coordinate the logistics of Artiva product readiness with sites and internally within Artiva. Work cross-functionally with product manufacturing, QA and supply chain management, to coordinate site training, product delivery, supply management to ensure readiness and product availability prior to patient treatment.
- Developing and maintaining good working relationships with CRO, investigators and study staff.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Ensure timely response to queries and monitoring discrepancies.
- Manage the investigational product (IP) and non-IP study drug accountability and reconciliation process.
- Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers.
- Perform clinical data review of data listings and summary tables, including query generation.
- Perform initial review of CRO and other third-party study vendor invoices for correctness.
- Plan and conduct investigator meetings as directed.
- Review key study quality metrics (e.g. patient eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
- Review and/or approve IP release packages.
- Tracking and reporting on current progress of the study including site activation, patient enrollment, monitoring visits and data submission backlogs.
- Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents.
- Participate in the planning of quality assurance activities, coordinating the resolution of applicable audit findings.
- Ensure audit-ready condition of clinical trial documentation including central clinical files; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinates and assist in the planning of regulatory or ethics committee activities, as appropriate.
- Collaborate with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).
- Prepare and/or review study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
- Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
- Manage clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc.
- Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
- Undergraduate degree in life sciences or relevant work experience. Graduate degree preferred.
- Therapeutic experience in autoimmunity is strongly preferred.
- Five or more years' experience managing clinical trials as the sponsor is preferred; prior working experience at a site or in a CRO is a plus.
- Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.
- Experience monitoring sites and conducting other site management activities.
- Ability to work in a fast-paced environment and flexibility
- Proven experience in early phase clinical trials.
- Strong site management and CRO management skills required.
- Proven communicator, both oral and written.
- Travel up to 30%
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, , is where you can trade in points earned for things you want.
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Sr. Clinical Trials Manager - San Diego, United States - Artiva Biotherapeutics
Description
About Artiva:
Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale.
Our lead program, AlloNK, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers.
AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed's innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.
Job Summary:
The Senior Clinical Trials Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock.
Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations and guidelines governing the conduct of clinical trials.
The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.
Duties/Responsibilities:
Requirements:
Why you should apply:
We have a fantastic team and philosophy We are passionate - we deeply care about our team, our science, and improving the lives of cancer patients.
We are tenacious - laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.
We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive - committed to the diversity of our team and ensuring that all voices are heard.In addition to a great culture, we offer:
Artiva Biotherapeutics is an equal employment opportunity employer.
Base Salary:
$155,000 - $165,000. Exact compensation may vary based on skills and experience.
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