The Senior Clinical Trial Manager will report to the Director of Clinical Affairs and Data Management. The principal function of the position is to manage the execution of a portfolio of multicenter investigational device exemption clinical trials. In particular, the role assumes complete responsibility for clinical study planning, development, and launch as well as the execution of day to day study and data management activities. Success in this role is tied to establishing strong internal and external relationships, ensuring the highest integrity of the data collected, and for each study to achieve its intended goals on time and within budget while ensuring transparency and communication across the team and organization.
Responsibilities
Study Development and Leadership
- Support the development of clinical study protocols and related regulatory submissions
- Develop and manage study budgets and timelines, including personnel resource estimates
- Manage operational aspects of multiple clinical trials, with competing deadlines, from study start-up through database lock in compliance with ICH/GCP, company SOP, and other regulatory requirements as relevant to the study
- Proactively manage multifunctional clinical study teams to a identify and manage critical path activities, and achieve deliverables within the larger context of corporate goals
- Ensure that team members are appropriately trained on study conduct and company procedures
- Assist in the development of internal SOPs and processes to ensure ongoing study compliance
- Maintain inspection readiness and participate in FDA or other regulatory authority inspections
- Manage study-related vendors, including review of and input on vendor contracts, SOWs, proactive management of issues, and assistance with invoice reconciliation
- Liaise between corporate finance/legal counsel and investigator institution and vendor representatives relative to the establishment of and adherence to contractual agreements
- Establish and maintain strong working relationships with internal and external teams
- Provide frequent study updates to internal teams, including senior management, and external partners
Documentation and Data
- Develop and implement clinical study processes to support study and data management operations
- Ensure development and implementation of applicable study plans (i.e., clinical trial monitoring plan), protocols, amendments, informed consent templates, CRF forms/completion guidelines and site reference guidelines/instructions
- Manage EDC database specifications, eCRF design, clinical database validation, eCRF completion guidelines, and data management and review plans to ensure high data quality and compliance with applicable industry regulations and standards
- Review protocol deviations and data listings to ensure sponsor oversight
- Manage data query, review, cleaning process to minimize data inconsistencies, errors, or omissions
- Work with data management, statisticians and research scientists to optimize the workflow for study endpoint and adhoc dataset creation and data analysis
- Work with data management to ensure timely database locks for all assigned projects