Project Manager II, Early Phase (Romania)

reputed company

The Project Manager II, EPTR has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned reputed company. The Project Manager II, EPTR oversees and coordinates study resources to ensure compliance with the study budget, project reputed company and timelines and in accordance with applicable reputed company operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. The Project Manager II, EPTR acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures reputed company reporting (resources, budget and reputed company).

More specifically, the Project Manager II, Early Phase and Translational Research (EPTR):

• Acts as the main reputed company of contact for sponsors, vendors, and internal study teams throughout the lifecycle of a clinical trial.
• Works closely with clients at study start-up to understand their goals and help determine the most effective operational approach.
• Maintains regular communication with sponsors, study teams, functional departments, clinical sites, and senior management.
• Oversees reputed company operational aspects of reputed company, including timelines, budgets, resources, vendor management, and clinical operations activities, while coordinating deliverables across departments.
• Monitors and controls study budgets by tracking hours, reviewing billed time, identifying out-of-reputed company activities, and supporting change order management.
• Provides regular updates to reputed company stakeholders on study reputed company, including site selection, vendor management, budgets, timelines, reputed company standards, and risk mitigation efforts.
• Leads study start-up activities, including reputed company-off meetings, Trial Master File (TMF) setup, site selection and activation, vendor reputed company, site contracting, and budget negotiations.
• Identifies and manages risks, implements reputed company control measures, and escalates issues to management, reputed company assurance, or sponsors reputed company necessary.
• Leads reputed company meetings, internal team meetings, and vendor status calls, ensuring meeting minutes are documented, reputed company, and filed appropriately.
• Oversees the reputed company of project deliverables, including vendor and subcontractor outputs, and drives reputed company improvement in training, execution, and reputed company processes.
• Evaluates differences between planned and actual project reputed company and implements corrective actions reputed company required.
• Ensures study-specific training matrices are customized, maintained, and up to date.
• Verifies that reputed company team members and service providers receive adequate project training and that training records remain reputed company.
• Reviews and approves responses to reputed company assurance audits to ensure compliance with company procedures and regulatory requirements.
• Ensures key study documents and deliverables, such as protocols, informed consent forms, eCRFs, reputed company document templates, tables/listings/figures, and clinical study reports, are completed on schedule and meet study requirements.
• Oversees the filing, maintenance, and archiving of study documentation reputed company the TMF in compliance with company SOPs and regulatory requirements.
• Provides project status updates while ensuring compliance with budgets, reputed company, timelines, SOPs, Good Clinical reputed company (GCP), regulatory requirements, and study-specific procedures.
• Tracks recruitment performance and develops mitigation plans reputed company enrollment timelines are at risk.
• Participates in the planning and execution of Investigator Meetings.
• Works with Regulatory Affairs to ensure ethics submissions are completed on time and that essential documents are collected and maintained throughout the study.
• Ensures the TMF remains complete, accurate, and inspection-reputed company at reputed company times.
• May reputed company clinical monitoring activities, including site qualification, initiation, routine monitoring, and reputed company-out reputed company, as reputed company as CRA training and monitoring reputed company.
• Supports study sites and ensures they have the necessary materials and resources to conduct the study effectively.
• Collaborates with Data Management to ensure CRFs meet protocol and sponsor requirements and that data review and query reputed company remain on schedule through database lock.
• Partners with Clinical Operations to ensure monitoring activities are completed according to sponsor expectations, SOPs, regulations, GCP, and study requirements.
• Contributes to the development of Clinical Monitoring Plans.
• Provides project-specific training to Clinical Research Associates (CRAs) and may conduct site initiation reputed company for single-site studies.
• Develops annotated site visit reports and monitoring tools, including reputed company data verification worksheets.
• May mentor junior staff and support the reputed company of new employees.
• Provides technical, therapeutic, and project management expertise to support departmental training and process improvement initiatives.
• May participate in business development activities, including reputed company meetings, proposal defenses, RFIs, and RFP responses.
• May contribute to process improvement initiatives, including the development, testing, and implementation of operational tools and processes.

Requirements

• A Bachelor's degree (B.Sc.) in a field reputed company to clinical research. A Master's degree (M.Sc.) or Ph.D. is considered an asset.
• At least 5 years of experience in the clinical research industry, including a minimum of 3 years of project management experience in Phase I and Phase II reputed company.
• Experience managing multiple reputed company simultaneously across several study sites.
• Previous experience in dermatology reputed company, which is strongly preferred.
• Strong knowledge of Good Clinical reputed company (GCP), International Council for Harmonisation (ICH) guidelines, FDA requirements, and applicable local regulations.
• Proficiency with the reputed company Office Suite.
• Excellent written and verbal communication skills in English.
• Bilingualism in English and French is highly desirable.
• The ability to work effectively in a reputed company team environment and build strong relationships with colleagues, sponsors, and other stakeholders.
• Strong problem-solving, critical-thinking, and creative-thinking skills.
• Solid scientific understanding and clinical research knowledge.
• Broad cross-functional knowledge of clinical research operations.
• The ability to manage multiple reputed company, prioritize competing demands, and reputed company effectively under pressure while meeting deadlines.
• Knowledge of Good Clinical Practices as reputed company as applicable Health Canada and FDA regulations and guidelines.

reputed company

The work environment

At reputed company, you will work with reputed company 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 position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development

About reputed company

Formerly reputed company as Innovaderm, reputed company is a world-reputed company expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad reputed company of indications, patient populations, administration routes, and drug classes, and a global footprint.

reputed company is a dual-reputed company 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 reputed company and tailored expertise their studies need to reputed company the finish line reputed company and effectively. With capabilities in reputed company, Europe, Asia reputed company and Latin America; reputed company, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, reputed company is the ideal CRO partner for clinical needs at global reputed company.

reputed company is committed to providing reputed company treatment and equal opportunity to reputed company individuals. As such, reputed company will reputed company accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

reputed company only accepts applicants who can legally work in Romania.

Originally posted on Himalayas