Senior Clinical Project Manager

Location
San Diego, CA
Posted
Jul 10, 2019
Required Education
Bachelors Degree
Position Type
Full time

Position Summary

Responsible for successfully planning and overseeing the implementation and execution of multiple clinical studies (U.S. and Ex-U.S. global studies). Guides the operations of effective clinical strategies to support corporate initiatives. Demonstrates expertise in all areas and phases of clinical study development and execution and an ability to manage effective multi-disciplinary project teams. Contributes to and optimizes department systems and procedures. Must maintain required quality standards in a timely manner, within a managed budget, as well as managing CROs and vendors. This position reports to the Director, Clinical Operations.

 

Responsibilities

  • Lead execution of clinical operational objectives and creates development strategies in accordance with the Clinical Development Plans and project plans
  • Lead internal/external study team(s) to ensure effective implementation and execution of clinical trials and leads the execution of clinical trial projects, within agreed timelines, resources and budgets
  • Provide input on study strategy development, protocol, CRF development, Clinical Study Report preparation, and NDA submission, as appropriate
  • Develop and maintain study timelines and optimally manage study budgets
  • Identify project risks, develop and implement mitigation strategies for assigned projects
  • Prepare metrics and updates, as assigned
  • Participate in and facilitate CRO/vendor selection process for outsourced activities
  • Oversee CRO interactions, including sponsor oversight of operational functional activities, such as study management, training and monitoring
  • Participate in the development, review and implementation of departmental SOPs and
  • Participate in and/or lead meetings, working groups or initiatives, as required (preparing/maintaining agendas, meeting minutes, action items)
  • Ensures assigned projects are “audit ready” at all times

 

Minimum Qualifications      

  • Bachelor’s degree in related scientific or healthcare field; a combination of relevant education and applicable job experience may be considered.
  • Minimum of 8 years of related clinical operations and drug development experience, including 4+ years of U.S./Ex-U.S. global clinical trial management experience
  • Experience with Phase 1 through 4 trials, both domestic and international
  • Infectious Disease clinical trial experience desired
  • Proven ability to lead a study team
  • Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
  • Working knowledgeable of FDA regulations and ICH GCP guidelines
  • Ability to manage complex and fast paced clinical operations activities that may require dealing with time demands, incomplete information or unexpected events
  • Must possess excellent planning and interpersonal skills
  • Must have the ability to build and maintain positive relationships with management, peers, and direct reports
  • Excellent written, verbal and presentation skills required. Must display strong analytical and problem solving skills
  • Willing to travel domestically and internationally approximately 15% of the time

 

The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company