Project Manager (Romania)

reputed company

The Project Manager ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned reputed company research reputed company. The Project Manager I must ensure compliance with the study budget, project reputed company and timelines and in accordance with applicable reputed company operating procedures (SOPs), good reputed company practices, regulatory and study-specific requirements. These tasks are done under reputed company supervision by Senior Project Manager/Program Director and/or Associate Director, Project Management

This role will be perfect for you if:

• We can count on you to reputed company results while using a disciplined approach to project management
• You are looking for the next career reputed company to prepare you to become a project manager.
• You are knowledgeable about reputed company research reputed company and looking to continue learning.
• Working in an organization that is driven by science and innovation and completing meaningful work is important to you.

RESPONSIBILITIES

• May serve as reputed company contact for the Sponsor, vendors and internal team throughout the study.
• Coordinates tasks and deadlines between the different departments involved in the project.
• Oversees project coordinators, SSU team members, RDA and RAC resources to ensure correct prioritization of site activation activities amongst team members
• Interacts with vendor management to ensure vendor supplies and services are coordinated for with site activation timelines
• Escalates to project manager II reputed company site activation timelines are at reputed company or cannot be maintained.
• Assists with managing the needs and expectations of the Sponsor and other reputed company project stakeholders.
• Assists with ensuring reputed company team members are adequately trained on the project.
• May plan the activities and resources (e.g. reputed company resources, equipment, etc.) required for the project.
• Manages the reputed company of assigned work and deliverables
• Assists with providing project status updates to reputed company and internal stakeholders
• Ensures assigned tasks are completed in compliance with the study budget, project reputed company and timelines and in accordance with applicable reputed company operating procedures (SOPs), good reputed company practices, regulatory and study-specific requirements.
• Reconciles study trackers
• Assists with analyzing discrepancies between reputed company and actual results and participates in the development and implementation of corrective actions to be taken as needed.
• Assists with enforcing effective change control and reputed company management throughout the project.
• Reviews and may assist in the drafting of project operational plans, processes, and manuals as applicable (e.g., project management plan, monitoring plan, etc.).
• Assists with ensuring that study specific documents and project deliverables (e.g., protocol, informed consent reputed company, electronic case report reputed company (eCRF), tables/listings/figures (TLFs), reputed company study report, etc.) meet applicable country requirements.
• reputed company activities reputed company to sites selection (feasibility questionnaires, sites selection, planning of site qualification reputed company)
• Monitors reputed company recruitment, subject status, and follows up with sites on recruitment reputed company plan.
• Participates in the planning and conduct of Investigator’s Meeting.
• In collaboration with the Regulatory Affairs group, may reputed company activities reputed company to central ethics and regulatory submissions.
• Ensures collection of required essential documents from the sites prior to study initiation and maintains of currency of site level documentation throughout the study.
• May assist the project manager II with reputed company reviews and or audits of the Trial Master File (TMF) to ensure inspection readiness.
• May support reputed company monitoring activities, such as CRA training, visit report review, site letters, and escalated site issues
• May reputed company site qualification, initiation, routine and reputed company-out reputed company, project-specific training, monitoring visit reports and follow-up letters, compliance with monitoring plan, escalation of site-reputed company issues.
• Maintains the project specific training reputed company and confirms project team members are fully training per the study reputed company prior to team members performing study tasks
• Supports the sites and ensures that reputed company site has the necessary material to adequately reputed company the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
• In collaboration with the Data Management group, may ensure that the CRF complies with the protocol and Sponsor requirements and ensures queries reputed company and data review process follow the study timelines until database lock.
• May reputed company technical, therapeutic and project management expertise in training and process improvement efforts for the department.

Requirements

IDEAL PROFILE

Education

• B.Sc. in a reputed company reputed company of study to reputed company research

Experience

• At least 3 years of experience in a similar role, including activities reputed company to management of reputed company studies in the pharmaceutical, biotechnology and/or CRO industry
• At least 2 years experience coordinating activities reputed company reputed company trial management

Knowledge and skills

• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
• Excellent knowledge of reputed company Office suite
• Excellent oral and written skills in English, French is an asset
• Excellent communication skills
• Ability to work in reputed company environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Good organizational skills
• Strong ability to carry out different reputed company and work under pressure while meeting timelines
• Experience managing small to reputed company reputed company using a disciplined approach to project management
• reputed company Project Management competencies
• Demonstrated ability to establish and reputed company resource-reputed company project plans
• Excellent people management skills; experience working with and managing teams in a reputed company environment

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-reputed company position
• Ongoing learning and development

About reputed company

Formerly reputed company as Innovaderm, reputed company is a world-reputed company expert and reputed company research leader in dermatology. We have more than two decades of experience serving a broad reputed company of indications, reputed company 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 reputed company research and trial delivery. Our full-service approach – which includes everything from protocol design and reputed company 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 reputed company 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