Project Manager

📋 Description

• • Alira Health is seeking a dynamic and experienced Project Manager to join our global Clinical team, playing a pivotal role in the successful execution of clinical research studies. This is an exciting opportunity to contribute to a company dedicated to humanizing healthcare and life sciences through innovation, expert guidance, and a patient-centric approach. As a Project Manager, you will be instrumental in ensuring that clinical trials are conducted efficiently, ethically, and in strict adherence to regulatory standards, ultimately contributing to the advancement of life-saving therapies.
• • You will be responsible for the end-to-end management of one or more clinical research study protocols. This involves meticulous planning, execution, and oversight, ensuring that all activities align with the approved scope of work, budget, and established timelines. Your role will be critical in maintaining the integrity and quality of the research conducted under your management.
• • A key aspect of your responsibility will be serving as the primary study lead and the main point of contact for study sponsors. This requires exceptional communication and relationship management skills, fostering trust and transparency through frequent, accurate, and comprehensive study status updates and reports. You will be the face of Alira Health for these critical partnerships, ensuring sponsor satisfaction and clear understanding of study progress.
• • You will oversee and coordinate various clinical study functions, which may encompass a wide range of critical areas. This includes, but is not limited to, investigational product supply management, interactive web/voice response systems (IWRS/IXRS), data management, biostatistics, pharmacovigilance, and central laboratory services. Your ability to manage these diverse components will be crucial for the overall success of the study.
• • A significant part of your role will involve supervising, mentoring, and providing support to the Clinical team. This includes guiding Clinical Assistants, in-house Clinical Research Associates (CRAs), and field CRAs, as well as potentially supervising and training Associate Project Managers. Your leadership will foster a collaborative and high-performing team environment, ensuring that all team members are equipped to meet study objectives.
• • You will be responsible for the creation and thorough review of essential clinical study documents. This includes, but is not limited to, study protocols, informed consent form (ICF) templates, detailed study budgets, site log form templates, comprehensive study manuals and plans, and site binders. Accuracy and compliance in these documents are paramount.
• • Driving and facilitating effective clinical teamwork and communication is a core responsibility. You will ensure seamless collaboration among all stakeholders, both internal and external, to ensure the timely attainment of critical trial milestones. Proactive problem-solving and clear communication channels will be your tools.
• • Ensuring the accuracy of all reports and work products generated by the study team is essential. You will implement quality control measures and review processes to guarantee the reliability and integrity of the data and documentation.
• • You will provide essential monthly billing information to the finance team, ensuring accurate and timely financial reporting for the studies under your management.
• • Presenting at key project meetings, such as investigator meetings and new client meetings, will be an integral part of your role. This requires strong presentation skills and the ability to articulate complex information clearly and concisely.
• • Maintaining accurate and regular updates to management through frequent and transparent communication is vital. You will proactively identify potential issues, develop strategic problem-solving approaches, and implement solutions to ensure that study timelines are consistently met.
• • Managing subject accrual, retention, and compliance is a critical performance indicator. You will work closely with sites to monitor and optimize these aspects of the trial.
• • You will assist in the management of the Trial Master File (TMF) and conduct TMF reviews as needed, ensuring that all study documentation is complete, accurate, and readily available for audits and inspections.
• • Preparing for and actively participating in third-party audits and FDA inspections is a crucial responsibility. You will ensure that the study team and documentation are audit-ready at all times.
• • Strict compliance with ICH GCP guidelines, FDA regulations, and company Standard Operating Procedures (SOPs) is non-negotiable. You will ensure that you and your team adhere to all applicable regulatory requirements and internal policies.
• • You will participate in internal, client sponsor, scientific, and other relevant meetings as required, contributing your expertise and insights.
• • Performing additional duties as assigned will demonstrate your flexibility and commitment to the success of Alira Health and its clients.
• • This role offers a unique opportunity to work in a global, collaborative environment that values innovation, initiative, and diverse perspectives. You will be part of a team that is passionate about making a difference in healthcare and improving patient outcomes.