Senior/Clinical Project Manager
23 hours ago
Company Description ARTHEx Biotech is a clinical-stage biotechnology company focused on developing innovative medicines through the modulation of gene expression. 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.
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. CPM, will work collaboratively within the company, with the Director, Clinical Project Management, and with CROs/vendor partners to plan and execute clinical trials. 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.).
Provide administrative oversight and support to ensure smooth project operations, including budget management, contract negotiation, and vendor 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.
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
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. Contribute to a collaborative and high-performing team culture, ensuring effective communication and coordination throughout the project
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
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
Fluent in English
Knowledge of all aspects of clinical operations, from protocol concept through clinical study reporting etc.
Neurology therapeutic area experience preferred
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.
Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organizational skills, communication and quality orientation
Demonstrated ability to manage complex projects, deliver expected deliverables in a timely manner, and proactively communicate changes in pre-established goals and deadlines
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