Project Manager II (Romania)

DescriptionThe project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline)This role will be perfect for you if: You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projectsYou are looking to position yourself in an environment where you can grow your career alongside the companyIMPACT AND RESPONSIBILITIES Client interactionsServe as primary contact for the SponsorProvide efficient and timely updates on trial progressLead client calls effectivelyProject planning Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.Participate in the planning and conduct of the Investigator’s Meeting.Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met.Quality and risk managementEnsure 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, 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, Scientific Affairs. Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study.RequirementsEducation B.Sc. in a related field of study to clinical researchExperience At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project managementExperience managing dermatology and/or rheumatology trialsExperience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.Experience managing dermatology trials an assetKnowledge and skillsExcellent knowledge of GCP and ICH standards, FDA and Canadian regulationsExcellent knowledge of Microsoft Office suiteExcellent oral and written skills in English, French is an asset Excellent communication skillsAbility to work in a team environment and establish good relationships with colleagues and sponsorsGood problem-solving abilitiesGood organizational skillsStrong ability to carry out different projects and work under pressure while meeting timelinesOur company The work environmentAt Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Permanent full-time positionFlexible scheduleVacationHome-based positionOngoing learning and developmentAbout Indero Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities 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 our own studies, Indero is the ideal CRO partner for clinical needs at global scale.Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.Indero only accepts applicants who can legally work in Romania.Originally posted on Himalayas

DescriptionThe project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline)This role will be perfect for you if: You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projectsYou are looking to position yourself in an environment where you can grow your career alongside the companyIMPACT AND RESPONSIBILITIES Client interactionsServe as primary contact for the SponsorProvide efficient and timely updates on trial progressLead client calls effectivelyProject planning Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.Participate in the planning and conduct of the Investigator’s Meeting.Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met.Quality and risk managementEnsure 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, 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, Scientific Affairs. Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study.RequirementsEducation B.Sc. in a related field of study to clinical researchExperience At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project managementExperience managing dermatology and/or rheumatology trialsExperience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.Experience managing dermatology trials an assetKnowledge and skillsExcellent knowledge of GCP and ICH standards, FDA and Canadian regulationsExcellent knowledge of Microsoft Office suiteExcellent oral and written skills in English, French is an asset Excellent communication skillsAbility to work in a team environment and establish good relationships with colleagues and sponsorsGood problem-solving abilitiesGood organizational skillsStrong ability to carry out different projects and work under pressure while meeting timelinesOur company The work environmentAt Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Permanent full-time positionFlexible scheduleVacationHome-based positionOngoing learning and developmentAbout Indero Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities 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 our own studies, Indero is the ideal CRO partner for clinical needs at global scale.Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.Indero only accepts applicants who can legally work in Romania.Originally posted on Himalayas