Project Manager – Europe

Job not on LinkedIn

🔥 1 minute ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects • Ensure compliance with study budgets, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements • Serve as primary contact for sponsors, vendors and internal teams throughout studies • Coordinate tasks and deadlines across departments • Oversee project coordinators, SSU team members, RDA and RAC resources and prioritize site activation activities • Coordinate vendor supplies and services with site activation timelines • Escalate risks to site activation timelines to Project Manager II • Manage sponsor and stakeholder needs and expectations • Plan project activities and resources • Manage quality of assigned work and deliverables • Provide project status updates to internal and external stakeholders • Reconcile study trackers and analyze discrepancies between planned and actual results • Participate in corrective actions, change control and risk management • Review and assist with drafting project operational plans, processes and manuals • Ensure study documents and project deliverables meet applicable country requirements • Oversee site selection and site qualification activities • Monitor patient recruitment and subject status and follow up with sites on recruitment strategies • Participate in Investigator’s Meetings • Oversee central ethics and regulatory submissions with Regulatory Affairs • Ensure collection and maintenance of essential site documents • Assist with Trial Master File quality reviews and audits • Support clinical monitoring activities, including CRA training, visit report review, site letters and escalated site issues • Track site qualification, initiation, routine and close-out visits, training, monitoring reports, follow-up letters and site issue escalations • Maintain the project-specific training matrix and confirm team training before study tasks • Support sites with investigational product, study supplies, equipment and safety lab kits • Work with Data Management to ensure CRF compliance, query resolution and data review through database lock • Provide technical, therapeutic and project management expertise in training and process improvement

🎯 Requirements

• B.Sc. in a related field of study to clinical research • At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry • At least 2 years of experience coordinating activities related to clinical trial management • Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations • Excellent knowledge of Microsoft Office suite • Excellent oral and written skills in English; French is an asset • Excellent communication skills • Ability to work in a team environment and establish good relationships with colleagues and sponsors • Good problem-solving abilities • Good organizational skills • Strong ability to carry out different projects and work under pressure while meeting timelines • Experience managing small to medium projects using a disciplined approach to project management • Demonstrated ability to establish and deliver resource-based project plans • Excellent people management skills; experience working with and managing teams in a matrix environment • Must be legally able to work in the EU

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Vacation • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request