Clinical Trial Manager/Senior Clinical Trial Manager

BLOSSOMHILL THERAPEUTICS INC•San Diego, CA

2d•Onsite

About The Position

The Clinical Trial Manager/Senior Clinical Trial Manager will lead the operational execution of clinical trials from start-up through close-out. This role is responsible for CRO and vendor oversight, study planning, timeline and budget management, and ensuring trials are conducted in compliance with regulatory requirements, ICH/GCP guidelines, and internal SOPs. The CTM/Senior CTM will proactively manage risks to ensure delivery of high-quality clinical data within timelines and budget. This role is an on-site position.

Requirements

Undergraduate degree in life sciences related field. Graduate degree preferred.
Therapeutic experience in oncology is strongly preferred.
Clinical Trial Manager – 5+ years
Senior Clinical Trial Manager – 7–10+ years
Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.
Experience monitoring sites and conducting other site management activities.
Experience working with clinical trial systems such as EDC, and eTMF, and IVRS.
Ability to work in a fast-paced environment and flexibility
Proven experience in early phase clinical trials.
Strong site management and CRO management skills required.
Proven communicator, both oral and written.

Responsibilities

Participate in vendor selection processes including RFP development, vendor evaluation, and contract scope development.
Develop and maintain good working relationships with CRO, investigators and study staff.
Ensure studies are conducted according to the study protocol, SOPs, and ICH/GCP regulations
Develop and maintain study timelines and operational plans; track study milestones and proactively identify and mitigate risks to study delivery.
Lead study start-up activities including site feasibility, site selection, site activation planning, and oversight of IRB/EC submissions.
Implement and oversee risk-based monitoring strategies and centralized data review activities to proactively identify study risks and ensure data integrity.
Perform high-level clinical data review of listings and summary tables to identify trends, data issues, and potential protocol deviations.
Ensure timely response to data queries and monitoring discrepancies. Assist with third-party vendor training on protocols and practices.
Develop and present study operational metrics and status updates to internal leadership and study governance teams.
Track and report on study progress including site activation, patient enrollment, monitoring activities, and data entry backlogs, and escalate risks to study timelines as appropriate.
Oversee investigational product (IP) accountability, supply management, and reconciliation activities. Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers.
Support study budget management including vendor budget tracking, forecasting, and review of change orders to ensure study execution within financial targets.
Perform initial review of CRO and other third-party study vendor invoices for correctness.
Review and/or approve IP release packages.
Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents.
Ensure ongoing inspection readiness and support regulatory authority inspections (e.g., FDA, EMA) as required.
Participate in the planning of quality assurance activities, coordinating the resolution of applicable audit findings.
Ensure audit-ready condition of clinical trial documentation including clinical trial master files; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate.
Lead cross-functional study teams including Data Management, Biostatistics, Regulatory Affairs, Medical, and Pharmacovigilance to ensure alignment on study deliverables.
Prepare and/or review study-related documents (e.g., Study Plan(s), Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
Manage clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc.
Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.