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 apexlifesciences.com 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
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)