Clinical Systems Project Manager

  • location: San Francisco, CA
  • type: Contract
  • salary: $55.71 - $65.54 per hour
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job description

Clinical Systems Project Manager

job summary:
Manager, Clinical Training

Job Summary

The Manager Clinical Training will provide focal training support across clinical development and operations. This role be the designated back up business system administrator for ComplianceWire and MasterControl, will aid in the development of training strategies and methods while being responsible for drafting the training materials and conducting the training sessions where appropriate. This role will act as a resource for the study teams but will not be solely responsible to develop protocol specific training. Coordinates the activities involved in the design, preparation, and delivery of training for clinical development and operations. Develops content and materials for training staff and new employees. Participates in the development of methods for evaluation of training effectiveness.

 
location: San Francisco, California
job type: Contract
salary: $55.71 - 65.54 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Interfaces with all GCP groups to provide support and oversight of training compliance.
  • Provides leadership in continuous improvement according to GCP and current industry standards..
  • Assists in the development of compliance and effectiveness metrics and provides training compliance and effectiveness updates to functional leaders within clinical development.
  • Ensure support of company priorities including regulatory inspections.
  • Provides support with documentation, tracking and archival of training processes and initiatives.
  • Responsible in a supporting role as back up for the client's Learning Management System (i.e. ComplianceWire).
  • Develops training for procedural documents including instructions courses, quizzes, exams and other training materials.
  • Coordinates development and maintains training curriculum with functional area input.
  • Responsible to design and develop the content and format of training materials for effective adult learning.
  • Responsible for organizing and presenting training sessions to groups or individuals.
  • Ensures training is appropriately captured and recorded within CompliancWire.
  • Responsible for group and individual training sessions, including scheduling, training material/media development, presentation and record keeping.
  • Participates in Learning Management System (LMS) administration.
  • Responsible in a supporting role as back up for MasterControl including maintenance of procedural documents across clinical development which may entail routing and approval of procedural documents and facilitating periodic reviews.
 
qualifications:
Education & Qualifications

  • A Bachelors degree in Training and Development or related discipline is required.
  • A minimum of 8 years experience in general training, GCP training or other related function is required.
  • A minimum of 3 years previous management experience is preferred.
  • Experience working in the Biotech, Pharmaceutical or other related industry is preferred.
  • Experience in a GCP setting and demonstrated success in establishing GCP training systems are highly desired.
  • Must possess excellent project management skills.
  • Strong verbal and written communication and presentation skills are required.
  • Must be goal-oriented, quality-conscientious, and customer-focused.
  • Must have experience delivering training courses to diverse audiences.
  • Experience working in a team-focus environment is preferred.
  • Must possess experience in needs assessment, design, preparation, delivery, follow up and tracking the desired outcomes of training and development programs for company management and employees.
  • Computer literacy (MS Word, Excel, PowerPoint, Visio) is required.
 
skills: Project Management, MS-WORD, MS-Powerpoint, GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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