Clinical Trials Manager, II

Location
San Diego, California
Posted
May 02, 2018
Required Education
Bachelors Degree
Position Type
Full time

General Summary:

Responsible for managing the clinical operations function and personnel assigned to the planning, execution and data collection activities on assigned clinical projects

Principal Duties and Responsibilities:

  • Participate on all project development teams
  • Provide regular updates to senior clinical operations management on the implementation and progress of all clinical development projects
  • Represent the Company externally in scientific, financial and business development communities
  • Create study documents for multiple studies (budgets, timelines, template forms)
  • Ensure that all studies are conducted in compliance with GCP, relevant SOP's & regulatory requirements
  • Manage multiple phase 1-3 US and global studies and assure process consistency between studies
  • Manage regulatory document collection process for multiple studies and assure consistency between studies
  • Create and manage the clinical trial master file for multiple studies and assure consistency between studies
  • Communicate daily with institution based clinical investigators/research staff (patient related safety, budget, data, monitoring staff, payments)
  • Efficiently oversee multiple vendors for multiple studies (laboratories, contract research organizations etc.)
  • Identify areas for process & technology improvement
  • Responsible for meeting enrollment goals, budget goals and timeline goals for multiple studies
  • Assist in protocol, informed consent and investigator brochure preparation
  • Contribute to annual report, IND, clinical study report and grant application writing
  • Contribute to other company related projects/departments as time allows
  • Co-monitor as needed
  • May have direct reports

Qualifications:

Education

  • Bachelor’s degree in a life science/Master’s preferred or its equivalent in health care or biological science. 

Experience/Skills

  • Minimum of two years of clinical operations experience in the biotechnology or pharmaceutical industry as at a manager level
  • Demonstrated understanding of all applicable regulations and guidelines governing drug development including ability to apply these to overall strategic drug development
  • Excellent working knowledge of Good Clinical Practices; ICH guidelines; trial initiation and management practices and procedures
  • Excellent leadership, interpersonal and communication skills.  Works efficiently with others to accomplish goals and resolve problems.  Encourages cooperation, collaboration, and co-ownership of processes
  • Experienced self-motivated individual with a record of achievement as a result of past industry experience.
  • Good conflict resolution and problem solving skills
  • Strong interpersonal skills and matrix management skills
  • Ability to develop a culture of teamwork, collaboration and communication.
  • Excellent written and verbal skills and the ability to communicate clearly, concisely and effectively
  • Open, available, transparent communicator with strong leadership, presentation and influence skills

Position Requirements:

  • Ability to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
  • Available to travel for training, scientific meetings and co-monitoring or to assist with complex, difficult clinical sites
  • Invest time to expedite and complete assignments or projects, as required
  • High energy level, winning approach and the ability to advance group goals to meet company objectives

NOTE: This description is not intended to be all inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job which may include other duties as assumed or assigned.