Clinical Trial Manager

X4 Pharmaceuticals, Inc.•Boston, MA

29d•$140,000 - $155,000•Hybrid

About The Position

Clinical Trial Manager Reporting to: Vice President, Clinical Operations Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work in 2023 by The Boston Globe, X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community. With the April 2024 U.S. approval of our first drug XOLREMDI (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day. If you feel you would be a good fit for X4, we invite you to share with us your aspirations and career goals. This opportunity will … Align with your values and grit, and passion for innovative science. Leverage your deep knowledge of clinical trials to support our innovative science and allow you to have a significant impact on our mission to support our patients. Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity. The Clinical Trial Manager plays a crucial role in supporting the Clinical Operations team in the day-to-day management and execution of clinical trials. This position combines operational management and vendor oversight, with an overall focus on study management.

Requirements

Bachelor's degree required.
5-7 years of relevant Clinical Operations experience in the biotech/pharmaceutical industry, minimum of 2+ years independent trial management experience preferred.
Excellent organizational and time management skills.
Demonstrated communication skills skillfully and clearly articulating timelines, deliverables, and study questions/issues in cross-functional and multi-level teams.
Prior experience successfully managing and developing study documents.
Known for proactive problem solving and success meeting deadlines and demonstrating effective use of time to meet priorities.
Able to manage multiple projects simultaneously, in a fast-changing environment.
Knowledge of ICH/GCP and regulatory guidelines.
Proven relationship and vendor management skills, with success moving through conflict.
Ability to lead study teams and build cross-functional relationships internally and externally.
Technical proficiency in MS applications such as Word, Excel, EDC, IVRS/IWR, etc.
Highly respected for commitment to integrity, professionalism, and respect for patients.

Responsibilities

Accountable for select aspects of clinical trial operations, including CRO and third-party vendor management, site management, and timeline and budget
Facilitate the request for proposal(s) process for selecting CROs or any new vendor and participate in the evaluation of potential services.
Create or assist in the development and/or review of study documents and systems (protocol, ICF, monitoring plan, study manuals, eCRFs, IVRS, etc.)
Own and/or support study timelines and study status and proactively communicate updates and risks to timelines, quality, and/or budget-related items.
Manage and monitor progress of study deliverables (ex. site activations, enrollment, etc.)
Accountable for the creation, management, and negotiation of clinical site budgets and/or sponsor oversight of third parties responsible for these activities
Accountable for study-specific budget activities including review and approval of vendor invoices, identification of out-of-scope activities and impact to overall budget, and support in monthly and annual forecasting.
Accountable for the management and/or support of monitoring (trip report review, creation and compliance to plan, etc.)
Assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
Communicate study status both internally and externally in terms of study risks and mitigation plans and develop proactive contingency plans for study-level risks.
Contribute or organize Investigator Meetings and CRA trainings.
Provide expertise to study drug and clinical supplies forecasting and help oversee proper drug accountability and reconciliation.
Oversee maintenance of study-related data and files in the Clinical Trial Management System (CTMS), if applicable, and electronic Trial Master File (eTMF).
Contribute to a culture of inspection readiness and support internal and external audits and inspections.
Ensure compliance with clinical trials requirements as well as any applicable Standard Operating Procedures (SOPs).
Provide input and coordinate the development of best practices and functional SOPs.