Apex Systems LLC
San Carlos
hace 12 días

Job Description

Apex Life Sciences is looking for a Sr. Clinical Trial Manager to join our growing Bio-pharma company, located in South San Francisco.

The ideal candidate MUST have at least 7 or more years' of Clinical Trial Management experience (Phase II / III preferred), and experience interacting with outside vendors / CRO's.

For immediate consideration, please send resumes to : mbingham Sr. CTM :

Essential Duties & Responsibilities :

  • Implements and manages operational aspects of trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH / GCP, and applicable regulatory requirements
  • Recognizes cross functional or company-wide impact of problems and considers implications in solution management while serving as an escalation point and resource for internal and external teams to help drive strategy and study initiatives
  • Accountable for quality data and meeting timelines and providing guidance to study team as needed
  • Participates in protocol, CRF development, Clinical Study Report preparation, as appropriate
  • Develops / prepares metrics and updates for management
  • Proactively identifies potential study issues / risks and recommends / implements solutions
  • Oversees and facilitates CRO / vendor selection process for outsourced activities
  • Manages CRO interactions, including sponsor oversight of operational function activities (eg, study management, monitoring, site management, trial master files)
  • May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Prepares and / or reviews / approves study-related documents (eg, Monitoring Plan, Study Manuals, and CRF-Completion Guidelines)
  • Reviews site study documents for accuracy and completeness (eg, informed consent template, study tools / worksheets, monitoring visit reports and letters, data listings, etc.)
  • Participates in interim and final report preparation for regulatory submissions
  • Reviews / approves vendor invoices and manages accruals and payment process for all clinical vendors including providing input to general study budgets, and identifying opportunities to reduce costs
  • Recommends and implements innovative process ideas to impact clinical trials management
  • Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Participates in the development, review and implementation of departmental SOPs and processes
  • May be assigned other projects and duties as required
  • Qualifications :

  • Experience in cell immunotherapy highly desired. Experience in transplantation a plus.
  • Strong demonstrated experience in interactions with outside vendors / CRO’s and management of vendors.
  • Requires proven project management skills and study leadership ability.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
  • Ability to multi-task and shift priorities quickly.
  • Must have excellent interpersonal, written and verbal communication skills.
  • Knowledge of FDA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.
  • Strong computer experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
  • EEO Employer

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