Project Manager, Vendor Management – Early Phase

Job not on LinkedIn

🔥 1 hour ago

🇦🇷 Argentina – 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 • Oversee and manage study-specific vendors throughout start-up, conduct and closeout • Coordinate vendor scope, timelines, deliverables, budgets, performance, documentation, risks, issues and escalations • Serve as a primary contact for Sponsors, vendors and internal teams • Coordinate tasks and deadlines across project departments • Oversee project coordinators, SSU team members, RDA and RAC resources • 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 • Support 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 planned versus 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 country requirements • Oversee site selection and site qualification planning • Monitor patient recruitment 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 • Support TMF quality reviews and audits for inspection readiness • Support clinical monitoring activities and track site visits, training, monitoring reports and site issues • Maintain the project-specific training matrix • Ensure sites have required study materials and equipment • Support CRF compliance, query resolution and data review through database lock • Provide clinical, therapeutic and project management expertise in training and process improvement • Oversee vendors to ensure services meet timelines, scope, quality and budget • Act as primary contact for assigned vendors • Review vendor work orders, budgets and scopes of work; support change orders • Monitor vendor performance, deliverables, timelines and milestones • Lead or participate in vendor meetings and document follow-up actions • Collaborate with subject matter experts to communicate study requirements • Review and approve vendor invoices • Manage vendor risks, issues and deviations and implement corrective actions • Support vendor quality events, non-conformances, CAPAs and performance improvement initiatives • Maintain complete and current vendor documentation in the TMF and other systems • Track vendor metrics and KPIs and provide stakeholder updates • Maintain positive vendor relationships while ensuring contractual and performance obligations

🎯 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 • Legally authorized to work in Argentina

🏖️ Benefits

• Flexible schedule • Vacation • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Recruitment and selection accommodations for applicants with disabilities, upon request

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