Sr Clinical Project Manager (Remote)

Company Description

ARTHEx Biotech is a clinical-stage biotechnology company focused on developing innovative medicines through the modulation of gene expression. The Company’s lead investigational compound, ATX-01, is being evaluated for the treatment of myotonic dystrophy type 1 (DM1), a rare neuromuscular disorder, in the Phase I-IIa ArthemiR™ trial. ARTHEx is also advancing its in-house discovery engine to identify and develop other treatments for disorders with high unmet medical needs, including genetically-driven diseases like DM1. The Company headquarters are in Valencia, Spain.

Purpose of the Role

The Sr. Clinical Project Manager (Sr. CPM) is responsible for oversight and leadership of one or more clinical trials conducted within the Clinical Department and for communication of information about these trials to stakeholders, as appropriate. The Sr. CPM, will work collaboratively within the company, with the Director, Clinical Project Management, and with CROs/vendor partners to plan and execute clinical trials. The Sr. CPM plays a key role in working with the study team to capture, analyze and report metrics on trial performance and adherence to plans (e.g., timelines, enrolment, data cleaning progress, budget metrics, etc.).  

Responsibilities

Administrative Support

• Provide administrative oversight and support to ensure smooth project operations, including budget management, contract negotiation, and vendor management

Document Management

• Oversee document management processes, ensuring adherence to SOPs and regulatory requirements

Regulatory Support

• Oversee regulatory submissions and approvals, ensuring alignment with GCP, ICH guidelines, and other regulatory standards
• Ensure the completion of clinical and regulatory documents such as Clinical Trial protocols, Investigator Brochures, Clinical Trial Applications, etc., writing and reviewing sections as required/directed.

Site Management Assistance

• Manage relationships with investigative sites and external vendors, ensuring effective communication and resolution of site-related issues
• Oversee site selection, activation, and monitoring activities, ensuring sites are compliant with study protocols, regulatory requirements, and relevant SOPs

Project Planning

• Develop and maintain comprehensive project plans, timelines, and budgets
• Collate study metrics, and develop and maintain a comprehensive dashboard that is reported regularly to management and other stakeholders

Team Coordination

• Engage with project team members, including CRAs, CTAs, and other staff involved in clinical operations to ensure success of study and achievement of corporate objectives  
• Manage vendors according to scope, budget and adherence to contract. Ensure any change orders are vetted with management and in place with the vendor prior to engaging in out-of-scope work
• Contribute to a collaborative and high-performing team culture, ensuring effective communication and coordination throughout the project

Leadership

• Provide direction for the study team, ensuring alignment with organizational goals and objectives

Planning and Strategy

• Ensure development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development. Lead bid defence, vendor selection and contract finalization meetings

Financial Management

• Manage project budgets, track expenditures, and ensure financial performance against budget
• Analyse financial data and provide insights for decision-making

Risk Management

• Proactively identify, assess, and mitigate project risks and issues
• Develop and implement risk management strategies to ensure project success

Qualifications

• BA or BSc in a scientific/life sciences discipline. Advanced scientific degree preferred (MD, PhD, PharmD, MSc, etc)
• Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry in clinical operations
• Understanding of different responsibilities and needs for other functions that support clinical trial execution
• Awareness of the sensitive and confidential nature of information and/ or situations
• Fluent in English
• Up-to-date knowledge of ICH GCP and applicable global regulations and guidance for clinical development
• Knowledge of all aspects of clinical operations, from protocol concept through clinical study reporting etc.
• Neurology therapeutic area experience preferred
• Proven interpersonal, written and verbal communication and organizational skills
• Commitment to teamwork
• Ability to travel as needed for investigator meetings, vendor auditing and oversight, internal team meetings etc.
• Ability to utilize various electronic systems and software- intermediate computer skills required. Proficiency in MS Office, specifically Outlook, Word, Excel, and PowerPoint; familiarity with MS Project is preferred
• Knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• Experience with health authority inspection such as with FDA, MHRA, MFDS, is a bonus, etc.
• Leadership qualities:  e.g. ability to train others, decision-making, problem-solving, negotiating etc.
• Risk management expertise, including issue identification, problem solving, decision making, and risk mitigation.
• Experience with multiple study phases, but especially Phase I and II
• Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organizational skills, communication and quality orientation
• Strong communication skill and professional presentation skill to deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions
• Demonstrated ability to manage complex projects, deliver expected deliverables in a timely manner, and proactively communicate changes in pre-established goals and deadlines