Senior Clinical Trial Manager 

The candidate must have prior experience managing clinical studies, CROs and vendors within a sponsor company.  The experience must include activities associated with clinical study conduct from start-up to close out, data clean up, and report generation.  A thorough understanding of FDA regulations, GCP and ICH are required along with strong interpersonal and organization skills.  Attention to detail is imperative.

  

Responsibilities

Sr. Clinical Trial Manager will be responsible to plan, execute, oversee and manage all operational aspects and progress of clinical trials with minimal oversight. The Sr. CTM will provide leadership within the department and guidance with regards to the operational aspects of executing deliverables. Will also be responsible for leading or contributing to department process improvement initiatives.  

 

Specific responsibilities include:

  • Drive all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.

  • Manage responsible study(ies) within agreed timelines and budget and in accordance with SOPs and GCP and coordinates cross functional efforts to achieve study objectives and goals. Identifies and communicates study issues that will impact budget, resources and timelines.

  • Manage vendors and investigator contracts, budgets, and reviews/approves/ processes invoices for payment Assists in the development of clinical trial budgets; supports efforts to revise budget forecast as needed; develops and maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported.

  • Review CRO progress reports, conduct Sponsor oversight of CROs, vendors (e.g. biomarker and specialty laboratories), CRAs and consultants performance to ensure trials and relevant program related activities are in adherence to ICH, GCP and Sponsor SOPs. 

  • Oversee and assist and/or maintain the ongoing tracking of clinical data (e.g. sample collection, and lab results)

  • Ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; Participate in data reviews, as needed.

  • Good organizational and time management skills.

  • Prepare study-related documents with functional team members including case report forms, study manuals, laboratory documents, and template informed consent forms.

  • Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.

  • Develop and oversees study quality metrics to ensure that subject recruitment goals are met; Provide study status updates (i.e., study start up, patient recruitment/enrollment, monitoring, risk mitigation plans and data collection) 

  • Review monitoring reports, follow up letters and reports from other outside vendors.

  • Provide guidance to study teams and investigative study sites to ensure consistency in interpretation of the protocol and study procedures.  

  • Forecast study drug and clinical study supplies for trials 

  • Plan and lead study related meetings; serve as an escalation point and resource for internal and external team members. Partner with cross functional groups to achieve deliverables

  • Responsible for mentoring internal Clinical Trial Managers and Clinical Research Associate /Clinical Trial Associates 

  • Participate in the development, review and implementation of departmental SOPs and processes.
     

Education / Experience / Skills:

  • Bachelor's degree (advanced degree preferred) plus at least 7 years clinical research experience within the pharmaceutical/Biotechnology industry

  • Minimum of 5 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance

  • Experience with oncology studies preferred. 

  • Working knowledge of FDA regulations and ICH GCP guidelines.

  • Experience with managing CROs, vendors and consultants.

  • Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.

  • On-site monitoring experience is preferred.

  • Strong interpersonal and communication skills (verbal and written)

  • Good organizational and time management skills.

  • Willing to travel (up to 20%) 

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