Senior Clinical Project Manager - Rheumatology

Senior Clinical Project Manager - Rheumatology (MUST HAVE EXPERIENCE WITHIN RHEUMATOLOGY AT PROJECT MANAGEMENT LEVEL)Location: Germany (Remote)

Salary: Up to €110,000 plus bonus

My client is a full-service global CRO focusing on the therapeutic area of Rheumatology and Dermatology. The founder of the business is a Medical Dermatologist and is therefore very passionate about these therapy areas.

With expansion in North America, Europe, Asia Pacific and Latin America, vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute their studies.

Project planning

• Oversee and actively participate in the preparation of project deliverables, including study plans, protocols, informed consent forms, electronic case report forms (eCRFs), tables/listings/figures (TLFs), and clinical study reports.
• Participate in the planning and conduct of the Investigator’s Meeting.
• Ensure that each site has the necessary materials to perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).

Quality and risk management

• Ensure assigned studies are “audit-ready” at all times.
• Monitor the quality of study deliverables (including vendor and SubCRO deliverables) and address issues as they arise.
• Manage risk and control measures to assure project quality.
• Analyze discrepancies between planned and actual results.
• Review and approve responses to quality assurance audits.

Project budget and timelines

• Control the project budget, with particular attention to internal hours allocated to all activities.
• Identify out-of-scope activities for change orders.
• Proactively manage operational aspects of the clinical trial, including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.
• Communicate effectively with study team members, functional departments, and senior management.
• Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.

Project team leadership

• Lead the core project team, which may include: Associate Project Managers, Project Coordinators, and Project Assistants.
• Ensure all team members have adequate training on the project.
• Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs.

Experience

• At least 6 years of industry experience, including a minimum of 3 years leading multi-center clinical trials (phase II-III)
• Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD
• Experience managing Rheumatology trials at Project Management level

• Please contact Chris Boateng at chris.boateng@arm.co.uk or apply via LinkedIn