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Senior Clinical Project Manager

Company: Akebia Therapeutics, Inc.
Location: Cambridge
Posted on: May 3, 2021

Job Description:

The Senior Clinical Project Manager (Sr. CPM) is responsible for orchestrating clinical operational activities across one or more compounds that are in development. The Sr. CPM executes high quality, integrated cross-functional plans for the project while adhering to appropriate standards and processes to ensure completion of project team goals in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

The Sr. CPM is responsible for the execution of one or more trials, or suite of clinical trials from protocol design to the final clinical study report and applies best practices in the development, initiation, planning, execution, control and completion of studies. This position coordinates the activities of functional groups that comprise the project team, in a matrix management structure, to ensure proper conduct and timely completion of all projects. Additionally, the Sr. CPM is responsible for coordinating efforts for the management of assigned studies both within the Company and through a variety of vendors.

This role may oversee one or more indications within a single compound or multiple compounds and is differentiated in responsibility by large, complex, global trials that require specialized technical and clinical expertise. Each indication will be developed in clinical studies performed on a global scale in coordination with international Clinical Research Organizations. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the Associate Director/Director of Clinical Operations or above.

Required Skills

  • Plan, initiate and execute clinical studies while adhering to budget, scope and schedule requirements.
  • Participate in creation and/or review of all supporting documents for a clinical study with minimal oversight - Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, ensure seamless integration between clinical objectives and study performance.
  • Develop and effectively manage budgets, timelines, and resources for assigned clinical studies and escalate variances within the established processes.
  • Develop study plans and lead system set-up.
  • Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
  • Manage and lead cross functional study teams, including vendors.
  • Ensure training of internal and external team members on appropriate SOPs and processes and effective training of study team, study sites and vendors of assigned clinical studies.
  • Responsible for up to date study and/or program information within relevant tracking systems and provide management with routine updates regarding the status of ongoing studies.
  • Proactively identify and resolve issues and manage escalation as appropriate.
  • Utilize appropriate systems and standard processes to ensure quality and consistency of operational activities across studies and indications.
  • Plan and execute Investigator Meetings, Advisory Board Meetings or other scientific meetings as required. Establish working relationship with clinical and internal and external medical experts to optimize and implement clinical studies.
  • Drive process of CRO review, selection, and negotiation for each study.
  • Develops and maintains relationships with external vendors and/or consultants and contractors.
  • Participate in the development and implementation of clinical operations standard operating procedures and common work practices within the team.
  • Participate in process improvement and quality related initiatives associated with study execution and deliverables. Participate in establishment of best-in-class processes and standards for study conduct.
  • May serve as subject matter expert (SME) in one or more areas such as systems, tools, best in class standards for operational execution etc.

Required Experience

Basic Qualifications:

  • BA/BS degree
  • 5 years of experience in clinical research operations of which 3 years must be direct study management experience in the pharmaceutical industry.
  • Global study experience.
  • Must have multi-trial, Phase2/3, global experience.
  • Experience in managing all stages of study conduct (start-up, maintenance and completion).

Preferred Qualifications:

  • BA/BS degree in science or nursing
  • Multiple therapeutic areas experience is desired.
  • Experience Managing CRO's and multiple Vendors
  • Demonstrated knowledge and experience in the global regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
  • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
  • Experience in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology.
  • Experience responding to audits and inspections.
  • Proven advanced project management expertise, including the leadership and development of cross functional teams and study team leadership.
  • Exceptional organization and attention to detail.
  • Excellent interpersonal, oral and written communication and presentation skills. Effectively present to leadership.
  • Fluent in English (oral and written).
  • Moderate travel (25%) may be required.

Keywords: Akebia Therapeutics, Inc., Cambridge , Senior Clinical Project Manager, Other , Cambridge, Massachusetts

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