Clinical Project Manager
Job Description
The Clinical Project Manager reports to the Director of Clinical Operations/QA who bears primary responsibility for managing Forbius obligations for execution of clinical trials. This position requires project management responsibilities and includes the development of tools to assist in source documentation of clinical trial oversight and quality control.
Responsibilities
• Quality reviews essential regulatory documents for study start up at research sites
• Provides oversight of eTMF system through audits twice a year. Documents findings and ensures corrective action plans are developed and implemented as applicable
• Authorizes release of Initial Investigation Drug Product to new sites and provides oversight of delivery
• Provides oversight of and assists in writing regulatory plans for clinical studies
• Ensures Standard Operating Procedures are established and maintained for all Formation Biologic delegated tasks
• Approves site payments and ensures processing after monitoring visits and query resolutions
• Participates in CRO activities as identified
• Assist in the management of the day-to-day clinical operations, including oversight of vendor deliverables (e.g., CRO)
• Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements
• Supports the Austin office in administrative tasks as requested (e.g., filing, data entry in logs, conference call invites, etc.)
• Assists in Phase 2 site selection to include feasibility data collection and on-site qualifications
• Assist in study start up activities at clinical locations
• Communicates milestones and report progress for the clinical studies
• Plans and participates in IM, KOM meetings and CRA training
• Ensure appropriate compliance with GCP, SOPs, guidelines and regulatory requirements
• Provides oversight of Close-out and Database Lock
• Reviews audit/monitoring reports for sites and works closely with Sites till resolutions
• Ensures open-communication between vendor and Forbius during trial conduct.
• Maintains clinical trial protocols on clintrial.gov
• Facilitates agendas and meeting minutes for Safety Calls with sites
• Close-out and Database Lock
• Other duties as assigned
Qualifications and Experience
• Minimum of 5 years' experience in Research and Clinical trials
• Held responsible roles in the conduct and management of Phase I and II clinical trials
• FDA Regulatory experience
• Minimum Bachelor’s Degree in health sciences (preferred)
• Proven ability to manage clinical trials and reach accrual goals
• Is a self- starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
• Willingness to offer full accessibility and thrive within a transparent work environment
• Ability to maintain confidential information with a high regard for integrity
• Excellent oral and written communication skills while continually demonstrating high levels of interpersonal versatility within diverse populations
• Strong strategic, analytical and critical thinking skills
• Ability to build relationships and establish credibility appropriately
• Self-reliant and results oriented. Drive balanced with patience
• Ability to prioritize and successfully execute multiple tasks simultaneously
• Excellent project management skills
• Proficiency with MS Office suite, Adobe, CTMS, etc.
How to Apply
Please submit your CV and cover letter in PDF format to careers@forbius.com. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.