Project Manager

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 budget, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements • Serve as primary contact for sponsors, vendors and internal teams throughout the study • Coordinate tasks and deadlines between departments involved in the project • 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 at-risk site activation timelines to Project Manager II • Assist with managing sponsor and stakeholder needs and expectations • Assist with team training and 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 in drafting project operational plans, processes and manuals • Ensure study documents and deliverables meet applicable country requirements • Oversee site selection and qualification activities • Monitor patient recruitment, subject status and site recruitment strategies • Participate in Investigator’s Meetings • Oversee central ethics and regulatory submissions in collaboration with Regulatory Affairs • Collect and maintain essential site documents throughout the study • Assist with Trial Master File quality reviews and audits for inspection readiness • Support clinical monitoring activities, including CRA training, visit report review, site letters and escalated site issues • Track site visits, project-specific training, monitoring reports, follow-up letters and site-related escalations • Maintain the project training matrix and confirm team member training before study tasks • Support sites with investigational products, study supplies, equipment and safety lab kits • Collaborate with Data Management on CRF compliance, query resolution and data review through database lock • Provide technical, therapeutic and project management expertise in departmental 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 experience coordinating activities related 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 • Applicants must be legally able to work in Romania

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Vacation • Home-based position • Ongoing learning and development • Attractive advancement opportunities