Summary:
The Lead Regional Clinical Site Manager (LRCSM) is responsible for overseeing and mentoring a team of RCSMs, providing guidance and support to foster strong relationships with clinical trial sites. This role will work closely with Clinical Operations Leadership in EU and ROW to ensure ensuring the successful execution of global clinical trials and effectively overseeing Gossamer's Contract Research Organization (CRO) partners. While working primarily within the global Clinical Operations team, the LRCSM will collaborate closely with other Gossamer field teams, including Clinical Development and Medical Affairs in their assigned region.
Essential Duties and Responsibilities
Supervision and Leadership
* Oversee and mentor a team of RCSMs (up to 4 individuals), providing guidance and support to ensure team members meet their performance goals
* May serve as the primary point of contact for CROs and sites in an assigned region, building and maintaining strong, collaborative relationships with investigators, study coordinators, and site staff.
* Manage relationships with key internal stakeholders, including Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Biometrics, and Quality Assurance.
* Proactively identify and address site-specific challenges, implement corrective actions, and escalate issues as necessary to ensure trial timelines and quality metrics are met.
* When needed, accompany CRO monitors on routine site visits to assess site performance, protocol adherence, data quality, and regulatory compliance.
* Facilitate efficient communication and information flow between CROs regional teams, sites and Gossamer study teams.
* Educate sites on protocol requirements, Good Clinical Practice (GCP), and relevant regulatory guidelines as applicable.
* Communicates study status reports to Project Team and Sr. leadership on a routine basis.
Communication & Collaboration
* Collaborate effectively with cross-functional internal teams, including Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Clinical Supply Chain, Quality Assurance and Medical Affairs.
* Present regional performance metrics, challenges, and solutions to internal stakeholders.
* Actively participate in study team meetings and contribute to strategic discussions.
* Mentor and support less experienced team members as appropriate.
Clinical Trial Execution & Compliance
* May perform electronic Trial Master File reviews for assigned regions/sites to ensure compliance and timely adherence to study plans.
* Oversee RCSMs and their assigned sites to ensure adherence to study protocols, GCP, regulatory requirements (e.g., FDA, EMA), and company SOPs.
* Proactively identify potential risks to study conduct and develop appropriate mitigation plans.
* Participate in internal and external audits and inspections, providing support and responding to findings as needed.
* Contribute to the development and review of study-related documents, including protocols, informed consent forms, and monitoring plans, as needed.
JOB QUALIFICATIONS
* BA/BS in a relevant scientific discipline required.
* Extensive experience in clinical site management, including previous supervisory or leadership roles.
* Minimum of 7+ years' experience in clinical operations or a relevant function within clinical development, with a strong focus on site management and CRO oversight in the pharmaceutical or biotechnology industry (CRO experience only may be considered).
* Experience in cardio-pulmonary or respiratory clinical trials strongly preferred.
* Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
* Working knowledge and experience with Word, PowerPoint, SharePoint and Excel.
* Excellent interpersonal skills and demonstrated ability to lead is required.
* Strong leadership and management skills, including the ability to motivate and inspire a team and make strategic decisions.
* Excellent verbal, written, interpersonal and presentation skills are required.
* Creative problem solver with the ability to address issues quickly and independently, balanced with judgement to escalate issues as needed.
* Strong attention to detail and dedication to accurate and high-quality work.
* Focus on results, highly collaborative cross functionally, and proactive.
* Effective time management skills and ability to manage competing priorities.
* Office environment / Domestic travel up to 30% and some International travel may be necessary.
* This role reports into our Dublin, Ireland office with remote working arrangements.
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.