- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 09/20/2022
- Website: synthekine.com
- Company Address: 1505 Obrien Drive, Suite A/D, Menlo Park, California 94025, US
About SynthekineSynthekine is an engineered cytokine therapeutics company developing disease-optimized treatments. The company uses immunological insights to guide targeted protein engineering to generate transformative medicines for cancer and autoimmune disorders.
The Clinical Trials Manager manages overall operation of one or more clinical studies including project planning, budget, resource management, and management of contract research organizations (CROs) and other key vendors. Ensures compliance with company SOPs, GxP, and regulatory guidelines. Recommends and implements innovative ideas to impact clinical trials management. Coordinates with departmental and corporate management to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders. Oversees clinical trials staff both internally and at service providers and manages all aspects of study operations. Acts as a cross-functional liaison to ensure study plan appropriately supports research questions and other goals of the company as needed. Ensures a positive, collaborative team environment and escalates issues to the supervisor(s) as appropriate.
- Leads all efforts in support of 1-2 clinical research protocols (depending on size and complexity) from protocol design to final deliverables, in accordance with specified timelines, budgets, and associated corporate goals.
- Participates in the assessment and selection of CROs, sites, and other vendors; may perform site or vendor qualification visits, request, and review proposals, and provide input on task orders and/or other project specifications.
- Acts as primary point of contact for CROs and other vendors as needed. Represents the company on periodic vendor calls, with or without management oversight, and ensures CRO personnel adhere to project specifications with particular attention to timelines, costs, and quality of deliverables.
- Coordinates critical decisions among key stakeholders including Synthekine personnel, scientific advisers, and vendor representatives. Escalates issues appropriately.
- Ensures that participating investigators adhere to GxP and applicable regulations by reviewing monitoring visit reports and direct engagement in direct communication with CRO personnel and Synthekine CQA or designee. Identifies and escalates any significant compliance issues to management.
- Takes personal responsibility for ensuring regulatory compliance and delivery of high-quality data via all appropriate means. Develops and exhibits facility with data management software as required to review clinical data and associated metrics, and address data quality issues directly with CROs and sites as needed.
- Assists with national regulatory and IRB/Ethics Committee submissions and responses to questions as required.
- Reviews and contributes to Clinical Study Reports, INDs, BLAs, and other clinical and regulatory documents.
- Represents the company as needed at professional meetings and presents clinical operations materials and provides training at such events as needed.
- Provides ongoing assessment and feedback on departmental policies and procedures toward increased efficiency and quality of deliverables. May contribute to the development of SOPs and other procedural documents.
- Develops metrics and reports as needed in conjunction with vendors, other clinical operations personnel, and Synthekine functional leads. Summarizes and presents these data as required.
- Bachelor’s degree, preferably in a scientific or health-related discipline.
- Minimum of 6 years of clinical and related experience with at least 2 years of clinical trial management experience in an industry setting such as a CRO or pharmaceutical company. Trial management experience gained at academic or other not-for-profit institutions involved in industry-sponsored research may supplement this requirement at the discretion of the hiring manager.
- Excellent understanding of GxP, ICH, FDA, EMA etc. regulations.
- Clinical experience/background (e.g., RN, PA, or medical office) also a plus.
- Demonstrated ability to develop positive working relationships with individuals and teams both inside and outside the company.
- Must have proficiency with MS Office as well as demonstrated ability to learn other project management and clinical trial software as required.
- Demonstrated ability to work independently, escalate issues appropriately, and to ensure a solutions-oriented approach to the identification and mitigation of risks to project milestones, budgets, and quality.
Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.