Clinical Project Manager, Clinical Operations

Cambridge, MA

JOB DESCRIPTION

JOB TITLE: Clinical Project Manager, Clinical Operations
EFFECTIVE DATE: August 15, 2019
CLASSIFICATION: Full time Employee
FUNCTIONAL AREA: Clinical
WORK LOCATION: Cambridge, MA
SUPERVISOR: Director, Clinical Operations
MANAGERIALLY RESPONSIBLE FOR: N/A

ESSENTIAL JOB FUNCTIONS:

  1. Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.
  2. Collaborate with internal and external team members for the planning and execution of clinical trials.
  3. Oversee all operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
  4. Accountable for coordination of planning, initiation, completion, and reporting of clinical protocols within or across programs from team endorsement to reporting.
  5. Ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan.
  6. Lead the development of and provide input into study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
  7. Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs).
  8. Collaborate with legal (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.).
  9. Organize and manage project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly.
  10. Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
  11. Monitor and visit clinical study sites as needed.
  12. Track, collect, and review clinical documentation for clinical trials.
  13. Complete other duties as assigned by the manager.

 

JOB SPECIFICATIONS:

  1. Minimum B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education.
  2. 5 – 7 years of experience and demonstrated success in managing complex clinical research/trials. Some experience in oncology preferred.
  3. Experience in CRO oversight is required.
  4. Strong organization, documentation and communication skills.
  5. Excellent interpersonal skills; ability to collaborate across disciplines.
  6. Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
  7. Ability to travel up to approximately 30% of time.

 

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity.  Employee may occasionally be required to travel.  The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to careers@kuraoncology.com