Clinical Trial Manager
1 week ago
Overview of Position:
Managing and meeting the objectives of clinical studies and programs by ensuring successful conduct of assigned clinical programs consistent with applicable regulations, Good Clinical Practice (GCP) and current standard operating procedures (SOPs). Accountable for meeting clinical study and milestones within scope and budget. Interface effectively with various clinical service providers. Establish working practices that promote and maintain a culture of inspection readiness at all times. Lead and provide oversight of operations activities of project(s) and/or program(s). Must be able to come onsite 3 days a week.
Essential Duties & Responsibilities:
Clinical Operations and Clinical Study Project Management:
* Lead clinical operations activities in the preparation and coordination of clinical trial set-up, maintenance and closure in accordance with GCP and SOPs.
* Provide study management by interfacing with representatives from key functional groups such as: Clinical Development, Data Management, Statistics, Regulatory Affairs, QA, Medical Writing, CMC, and Research
* Actively support other functional groups with clinical trial set-up, maintenance and closure (e.g. data management, statistics, medical writing, clinical trial material vendors, etc.)
* Provide expertise and direction on the activities involved with planning, conducting and reporting of clinical data.
* Lead trial initiation activities including protocol development, activities for investigator site selection and regulatory preparedness, investigator budget and contract negotiation, and clinical vendor procurement activities.
* Ensure overall study progress including development and maintenance of timelines, risk mitigation and contingency plans for all aspects of trial conduct, and management of study scope and change control.
* Actively engage in study oversight to monitor adherence to GCP with timely and appropriate escalation of issues as necessary.
* Participate in the development and review of regulatory documents as appropriate.
* Conduct site clinical site monitoring activities as needed.
* Other duties as assigned.
Vendor Management:
* Meet with and gather information on new vendors to build a knowledge base and maintain understanding of available services.
* Complete vendor proposal requests in conjunction with the contracts and outsourcing team as required and actively participate in the review and selection process of clinical vendors.
* Ensure adherence to business processes with respect to vendor contracts and invoicing procedures.
* Serve as key liaison with project and site management clinical research organizations (CROs) and monitor and track adherence to contracts and budgets.
* Participate in quarterly trial budget reviews and invoice reconciliation.
Quality and Process Improvement:
* Participate in development and review of clinical SOPs.
* Maintain 100% compliance with SOP training.
* Conduct audits and inspection readiness visits to investigator sites and vendors
* Promote and lead process improvement initiatives consistent with GCP operations and project management tools and concepts.
Job Requirements:
Education: BA/BS in Biological Sciences or related field, or BSN/RN
Experience:
* 5-8 years related experience in life sciences or medically related field, including 3 years of experience in industry within Clinical Operations (i.e. Manager level)
* Experience with development of prospective site-selection criteria
* Practical experience in initiating, maintaining and terminating clinical trials.
* Previous experience in leading cross-functional teams.
* Protocol development experience
* Familiar with advanced concepts of clinical research
* Ability to deal with time demands, incomplete information or unexpected events
* Experience with management of CROs or other vendor relationships.
* Experience with administration of budgets and grants
* Experience with reviewing adequacy of site-proposed documents for compliance with relevant regulations
* Experience managing Clinical Research Associates
* Previously conducted or managed trials in autoimmune and inflammatory conditions desired.
Skills and Attributes:
* Attention to detail
* Excellent time management and organizational skills
* Proven ability to manage multiple tasks and associated deadlines
* Exceptional and timely communication and interpersonal skills
* Strong computer literacy, including: Microsoft Project, Excel, Word, Outlook and PowerPoint
* Flexibility to adapt in a cross-functional and dynamic, "start-up" type environment
* Travel required 20-30%
Equal Opportunity Employer
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