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Sr. Clinical Project Manager

Company: Aeglea Biotherapeutics
Location: Austin
Posted on: June 14, 2019

Job Description:

Sr. Clinical Project ManagerLevel ExperiencedJob Location Corporate Office - Austin, TXPosition Type Full TimeEducation Level 4 Year DegreeJob Category BiotechDescription Position Summary:

The Sr. CPM (Senior Clinical Project Manager) is responsible for the proactive management of all aspects of Clinical Trial Team activities for assigned projects or programs. The Sr. CPM is accountable for achieving successful delivery of Aeglea clinical team activities at the project/program level by meeting company and regulatory requirements according to time, quality, scope and budget constraints.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

  • Proactively manage project or program level operational aspects of large and/or complex projects or programs

  • Lead Clinical Trial Team (CTT) including driving trial timeline, budget, resources and vendors without the need for significant input from their supervisor.

  • Proactively oversee project quality to insure project deliverables meet relevant quality and compliance standards within budgetary and timeline constraints

  • Provide effective and timely updates on trial progress to the Project Team and supervisor with respect to vendor selection, project plans, trial budget and timeline management, project execution, quality standards and risks.

  • Take initiative by leading project/program startup process, including but not limited conduct of Trial Kick-off meeting, oversight of the set-up of trial master file (TMF), oversight of site selection and finalization of site and vendor Clinical Trial Agreements and budgets.

  • In conjunction with relevant stakeholders, develop, implement and continually optimize effective project plans for each project/program

  • Proactively drive the Clinical Trial Team (CTT) to set priorities in accordance with applicable development plans, Target Product Profile, relevant budgets and company priorities

  • Assure adherence of CTT members to company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

  • Ensure potential study risks are effectively identified, assessed, managed and escalated

  • Ensure the CTT drives to successful completion of project milestones and deliverables within relevant time, cost and quality constraints. Either Chair the CTT or oversee subordinate who Chairs the CTT.

  • Support company financial operations as appropriate

  • May serve as line manager and/or mentor for less experienced Clinical Operations department staff

  • Other duties as assigned

    Qualifications Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

    Education/Experience: The ideal candidate will offer:

    • Bachelor degree in Life Sciences, Nursing Licensure or Pharmacy, is required. Master's, PMP and/or CCRP preferred

    • Prior clinical project management experience in a pharmaceutical or biotechnology company or CRO is required

    • Prior monitoring experience is preferred.

    • Relevant therapeutic experience preferred

      Knowledge, Skills and Abilities:

      • Read, write and speak fluent English; excellent verbal and written communication skills

      • Must have a in depth knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding GCP, drug development phases, clinical research and project management methods.

      • Able to effectively manage a portfolio of projects including managing individuals that are managing projects.

      • Able to modify own leadership style to motivate and achieve desired behavior in others

      • Demonstrated ability to clearly convey individual and team performance expectations and recognize positive contributions of others

      • Demonstrated ability to anticipate potential causes of conflict and takes preventive action

      • Demonstrated ability to coach others on effective communication tools and techniques

      • Demonstrated ability to assign tasks to challenge team members and stretch their capabilities considering the needs of the project

      • Demonstrated ability to show resilience in the face of change and positively engaging team to overcome difficulties and constraints

      • Demonstrated ability to balance conflicting and changing priorities effectively

      • Demonstrated ability to utilize innovative thinking to devise creative approaches to achieve objectives

      • Demonstrated ability to consistently translate complex ideas into clear written/verbal communication to gain team commitment

      • Demonstrated ability to effectively identify opportunities to enhance efficiencies on a project through optimal use of resources across the matrix

      • Demonstrated ability to proactively anticipate, manage and prevent potential conflicts that may occur on a project or across the matrix.

      • Demonstrated ability to set challenging objectives and monitor progress and quality against relevant metrics and analyses output.

      • Demonstrated ability to autonomously manage priorities in a timely manner while understanding how these vary during the course of a project and plan objectives accordingly to accomplish project goals within time, quality and costs constraints

      • Demonstrated ability to proactively identify and implement action and contingency plans to protect progress of the project

      • Demonstrates high level of organization to ensure delivery across a number of ongoing projects

      • Demonstrated ability to accept full accountability for owning the challenges of project delivery and inspiring the same in project team members

      • Understands cause and effect implications on a strategic project plan when presenting possible solutions

      • Recognize and anticipate potential risks, especially in complex situations, and escalate a comprehensive resolution plan that involves an analysis of the trade offs of time, cost and quality and recommends a course of action.

      • Demonstrated ability to motivate and persuade others through communication

      • Extensive experience with MS Project required

      • Extensive experience with startup, execution and close out of clinical trials is necessary

      • Self-directed with the ability to achieve challenging milestones with a minimum of supervision

      • Demonstrated ability to proactively produce quality results on time and within budget

      • Demonstrated ability to lead diverse teams in producing project deliverables on or before schedule while meeting relevant quality standards

        Work Environment: This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 30 % of work time.

        Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Keywords: Aeglea Biotherapeutics, Austin , Sr. Clinical Project Manager, Executive , Austin, Texas

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