Clinical Trial Manager

1 month ago

The Woodlands, United States Advanced Rheumatology of Houston Full time
Seeking highly motivated and experienced Clinical Trial Manager to oversee day to day operations of multiple clinical trials and research staff in the setting of a private practice rheumatology clinic.  Candidate must possess proven leadership qualities with excellent communication and interpersonal skills. 

Candidate must be competent in all aspects of clinical trial operations including but not limited to ethics committee submissions and approvals, study start-ups and close-out procedures, consenting process, deviation and adverse event reporting and documentation, data collection, source document development, query resolution, and investigational drug accountability processes and procedures.

Responsibilities: 
  • Lead research team and support staff including mentoring and training of new hires
  • Reviews new protocols and meets with site selection contact to determine site feasibility
  • Assigns new studies to appropriate research staff members
  • Ensures all research staff has completed required trainings and trainings are up to date
  • Conducts new study protocol/procedures review and training via presentation with the site staff prior to each new trial start up
  • Develops and negotiates trial budgets and terms of contracts
  • Ensures exceptional implementation of study protocols while strictly adhering to good clinical practice guidelines and site-specific SOPs
  • Able to identify and resolve study related problems
  • Ensures timelines are being met effectively and accurately to meet sponsor expectations
  • Can step in to perform clinical trial duties when necessary due to staff turnover
  • Ensures legal and regulatory compliance
  • Identifies inefficiencies in staff study related conduct or site resources and implements changes to improve
  • When appropriate, develops quality assurance methods and implements
  • Interacts with pharmaceutical trial sponsors, CROs, related vendors and site monitors
  • Prepares and presents monthly and annual status reports to site investigator
  • May be required to attend occasional off-site meetings

Qualifications:
  • Minimum of 3-5 years of clinical trial management experience with bachelors degree in science or related field. Masters degree preferred. 
  • Strong knowledge of GCP/ICH guidelines and regulatory (ethics committee) requirements.
  • Requires excellent written and verbal communication and time management skills.
  • Must be detail oriented and able to manage multiple studies and tasks simultaneously.
  • Compensation commiserate with degree and experience.

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