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Company: csci consulting, inc
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Clinical Operations Emeryville, CA Cambridge, MA Description Position Summary:

Position Summary: The primary role of the Global Clinical Studies Manager (GCSM) is to manage and execute one or more assigned clinical studies according to the objectives established by the project team and corporate goals. The GCSM will be responsible and accountable for all clinical operations activities related to the execution of the assigned clinical studies within the expected timelines, including:

  • Critical document development and review: Provide clinical operations input into clinical study protocol and informed consent form development. Create clinical operations and clinical study document templates for utilization by the study team, CRO and study sites. Direct the development of eCRFs and other data management documents in collaboration with the CRO. Facilitate/direct the development of other study/project plans as required.
  • Study management: Manage all aspects of clinical study execution. Lead the study execution team meetings. Work with cross-functional counterparts to ensure that operational activities are executed/delivered according to the expected timelines and budget. Identify, establish, and ensure that study operational activities track to key study milestones agreed with the project team.
  • Timeline and budget management: Manage study timelines and budgets. Provide monthly budget forecasts and accruals to Finance. Review vendor invoices for accuracy and to ensure adherence to budget. Approve vendor invoices. Track and initiate investigator grant payments. Assist/support the development of clinical study budgets as required.
  • Vendor management: Function as the primary day-to-day contact for assigned study vendors, including clinical CRO. Enable timely study setup, site activation, patient recruitment, data entry and query resolution, and issue resolution. Track and manage out of scope activities.
  • Oversight of site selection and management: Develop site training materials and manuals. Ensure selection of qualified investigators and sites. Facilitate review and negotiation of clinical site agreements. Negotiate site study budgets. Ensure execution of site contracts in line with planned timelines. Proactively identify and remediate study issues.
  • Site management: Function as the primary study contact for clinical sites for studies or study activities managed internally (eg., site startup). Enable timely completion of milestones (eg., site activation, data cleaning, etc.) to support corporate objectives. Perform site visits (PSV, SIV, IMV, COV), as required, to ensure adherence to study requirements.
  • Routine study tracking: Track key study activities (eg., country startup, site activation, patient recruitment, patient status, data collection, data review, etc.) and maintain study metrics for routine reporting to the internal project team and management. Develop study-specific tools to ensure timeliness, standardization and control of quality data.
  • Routine study communication: Provide relevant clinical study operations updates to the internal project team and management, including any variances to the timeline or budget. Proactively identify solutions for issues that arise in study execution.
  • Trial master file oversight: Establish and maintain TMFs in line with departmental SOP.
  • Contribute to departmental organization, including review/input into departmental SOPs, harmonization of processes across studies, and mentorship of junior team members.Minimum Education/Experience
    • Bachelor's degree (or equivalent), preferably in scientific discipline or a health- related
    • 7 years relevant industry experience, with at least 5 years in a clinical operations role (supporting or managing clinical trials) at a sponsor
    • Demonstrated proficiency in implementing, monitoring and managing clinical studies, from study startup to study
    • Thorough knowledge of ICH/GCP guidelines and FDA
    • Previous experience with global oncology or immunotherapy clinical studies preferred.Other Qualifications
      • Able to work effectively and collaboratively in a fast-paced, small start-up company environment.
      • Must be self-motivated, highly organized, detail-oriented and able to multi-task while delivering high quality
      • Excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
      • Strategic agility, strong critical and logical thinking with ability to analyze
      • Strong ability to prioritize and work in an evolving
      • Excellent presentation and written/verbal communication
      • Excellent computer proficiency (MS Word, Excel, PowerPoint).
      • Approximately 30% travel may be required. You have been redirected to a Gritstone Oncology job page

Keywords: csci consulting, inc, Cambridge , GLOBAL CLINICAL STUDIES MANAGER, Executive , Cambridge, Massachusetts

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