Clinical Project Manager

Global Clinical Project Manager

Join our dynamic team, at an innovative biotech, as a proactive and highly motivated Global Clinical Project Manager (CPM) to drive the operational success of our global clinical-stage projects focused on antibody drug conjugates (ADCs). As the CPM, you will oversee clinical trial activities (Phase I-III) and ensure the timely and budget-conscious completion of studies with the highest quality. Reporting to the CMO, you will manage the planning, implementation, and tracking of the clinical monitoring process, as well as administer the clinical trials while maintaining a comprehensive overview of the studies within the Trial Team.

Responsibilities:

• Take overall responsibility for Phase I-III clinical Projects, with potential expansion to subsequent trials as the program and portfolio grow.
• Lead the cross-functional Trial Team (TTT) and manage day-to-day operations of the clinical study, ensuring alignment with established goals, objectives, and budget, in compliance with SOPs/GCP/ICH/regulatory requirements.
• Manage interactions with multiple Clinical Research Organization (CRO) and clinical vendors/partners, coordinating clinical study timelines with Program Management to meet critical milestones.
• Proactively address issues that may jeopardize deliverables and resolve challenges during study conduct.
• Develop study plans and system set-up, perform country and site selection, and coordinate site management activities in collaboration with the team and CRO.
• Guide, author, audit, or edit study documents, including data reports, training materials, operational manuals, protocol development, Case Report Form (CRF), Informed Consent Form (ICF) design, and Clinical Study Report (CSR) writing.
• Facilitate the achievement of excellent data quality and oversee the trial budget.

Requirements:

• Neurology experience ideally ALS
• Experience designing, running and developing phase IIb clinical trials
• Thorough understanding of the drug development process with a strong knowledge of ICH and GCP guidelines.
• Extensive knowledge of clinical trial regulations, including US FDA and EMA
• Strong experience in the management of multiple CROs and other vendors.
• Influential and assertive communication skills (written and verbal).
• Proven project management abilities and study leadership.
• Ability to work independently and prioritise duties.
• Proactive team player, striving to find the best solutions in a collegial team environment.
• Fluent in written and spoken English.