Clinical Trial Manager
Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies.
The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.
Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting the cell types and biological mechanisms responsible for immune suppression in the tumor microenvironment.
General Position Overview:
The Clinical Trial Manager (CTM) is the primary operational contact for the Study Execution Team (SET) and responsible for the day-to-day operations of the study. The CTM provides operational leadership to the study team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs. The CTM should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study (ies) with effective communication across organization. This position may include line management responsibilities.
Key Accountabilities/Core Job Responsibilities:
Study Planning and Conduct:
- Responsible for all operational aspects and progress of clinical trial from a study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators
- Serves as an escalation point and resource for external teams/vendors and investigational sites
- Oversees/facilitates site feasibility/selection processes
- Develops/oversees subject recruitment/retention strategy and related initiatives
- Provides operational input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc.
- Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate
- Responsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations)
- Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and vendors
- Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
- Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
- Conducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed
- Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders
- Prepares metrics and updates for management
Financial Planning and Management:
- Collaborates in the development/management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines
- Reviews/approves vendor invoices and manages accruals and payment process for all clinical trial vendors including investigative sites
- Maintains completion of required corporate training on standards, policies, work instructions by due date
- Perform other work related duties as assigned
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
- Strong attention to detail and excellent organization skills
- Strong interpersonal skills and communication skills (both written and oral)
- Ability to work independently and prioritize duties
- Demonstrates effective time management with excellent problem-solving skill, multitasking and handles time sensitive demands
- Excellent sense of urgency to deliver at/surpass study conduct targets
- Strong leadership skills, self-motivated, adaptable to a dynamic environment
- Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools
Education and Experience Requirements:
- Minimum BA/BS or equivalent degree in scientific discipline
- 3+ years work experience for pharmaceutical company or related field
- Experience in interactions with outside vendors, e.g., CROs and other vendors
- Familiar with advanced concepts of clinical research and able to work effectively in a team environment
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a Clinical Development Plan
- Experience in oncology preferred
Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.