Posted to MedZilla on 5/26/2017


EPM Scientific

US-MA, Sr. Clinical Trial Manager 452431243662-MZ


 
 

JOB DESCRIPTION 
The Sr. Clinical Trial Manager will be responsible for providing operational support, planning, and execution of clinical trials. This includes the oversight and management of early and late-state clinical studies. Through leadership, direction, and operational expertise, the Sr. Clinical Trial Manager will contribute to the formulation of the overall clinical strategy and all supporting requirements. 

Responsibilities include, but are not limited to:
  • Prepare project plan including project timelines and deliverables.
  • Develop appropriate study tools and tracking systems.
  • Participate in contract research organization (CRO) qualification and selection, including budget negotiations.
  • Provide management and oversight of CROs to ensure compliance with quality measures.
  • Recruit qualified investigators for assigned studies.
  • Support data management plan and assist in development of data handling standards and conventions.
  • Prepare budget forecasts and management reports for assigned projects.
  • Proactively identify critical issues and develop mitigation solutions. Review and approve corrective action plans at individual site and across study.
  • Provide training, coaching and mentoring for project managers, monitors, clinical trial coordinators and direct reports.

Basic Qualifications:
  • Minimum 5 years relevant experience within clinical development.
  • BA/BS/RN degree in science or health related discipline.
  • Excellent communication skills; both written and verbal.
  • Experience with people management, medical documentation, clinical trial best practices, CRO vendor management, and process improvement methodologies.

Preferred Qualifications:
  • At least 2 years managing multi-disciplinary project teams.
  • Masters or Doctorate degree in science or health related discipline.
  • Uniquely qualified individuals with both technical and administrative competencies.
  • Ability to multi-task in a fast-paced environment with changing priorities and evolving problem sets.
  • Exceptional problem solving skills to drive effective and efficient clinical studies.
  • Strong analytical thinking capacity to understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines. 
Job Type: Full-time
Location: Cambridge, MA
Travel: 10-20%
Job ID: 015389

ABOUT
This company is a growing biopharmaceutical organization dedicated to developing innovative medicines for the treatment of multiple oncological conditions. Their mission is to provide substantial impact in patients’ lives through targeted therapies. Key collaborations, acquisitions, and accelerated development programs have led to an exciting pipeline of both complex mixture generic and novel drugs. 

Very competitive compensation packages have been authorized by the Executive Leadership team in order to achieve aggressive goals for the discovery and development of critical new therapies. 

EEO STATEMENT
EPM Scientific is proud to share our clients’ commitment to diversity and equal opportunity. Our recruitment practices do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


Please visit our website at www.epmscientific.com

 
 


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