Project Manager (Argentina)

Indero (formerly Innovaderm); Buenos Aires; Presencial; BRL 292 291 - 401 900; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible work schedule

Comprehensive benefits

Ongoing learning and development opportunities

Resumo da oferta

Indero is looking for a Project Manager to oversee clinical research projects, ensuring compliance with budget, scope, and timelines. The ideal candidate has at least 3 years of experience in a similar role within the pharmaceutical or biotechnology sector, with strong knowledge of GCP, ICH standards, and excellent communication skills. The role offers a flexible work schedule and a permanent full-time position with comprehensive benefits.

Qualificações

• At least 3 years of experience in a similar role, managing clinical studies.
• Experience coordinating activities related to clinical trial management.
• Knowledge of FDA and Canadian regulations.

Responsabilidades

• Oversee project coordinators and manage site activation activities.
• Coordinate tasks and deadlines between different departments.
• Ensure compliance with study budget and timelines.

Conhecimentos

Excellent knowledge of GCP

Excellent communication skills

Good problem-solving abilities

Excellent oral and written skills in English

Strong ability to carry out different projects

Formação académica

B.Sc. in a related field of study to clinical research

Ferramentas

Microsoft Office suite

Descrição da oferta de emprego

The Project Manager ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The Project Manager I must 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. These tasks are done under close supervision by Senior Project Manager/Program Director and/or Associate Director, Project Management.

This role will be perfect for you

• We can count on you to deliver results while using a disciplined approach to project management
• You are looking for the next career step to prepare you to become a project manager
• You are knowledgeable about clinical research projects 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 primary 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 with site activation timelines
• Escalates to project manager II when site activation timelines are at risk or cannot be maintained
• Assists with managing the needs and expectations of the Sponsor and other internal and external project stakeholders
• Assists with ensuring all team members are adequately trained on the project
• May plan the activities and resources (e.g., internal and external resources, equipment, etc.) required for the project
• Manages the quality of assigned work and deliverables
• Assists with providing project status updates to external and internal stakeholders
• Ensures assigned tasks are completed in compliance with the study budget, project scope and timelines and in accordance with applicable SOPs, good clinical practices, regulatory and study‑specific requirements
• Reconciles study trackers
• Assists with analyzing discrepancies between planned and actual results and participates in the development and implementation of corrective actions as needed
• Assists with enforcing effective change control and risk 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 form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) meet applicable country requirements
• Oversees activities related to site selection (feasibility questionnaires, site selection, planning of site qualification visits)
• Monitors patient recruitment, subject status, and follows up with sites on recruitment strategy plan
• Participates in the planning and conduct of Investigator’s Meeting
• In collaboration with the Regulatory Affairs group, may oversee activities related to central ethics and regulatory submissions
• Ensures collection of required essential documents from the sites prior to study initiation and maintains currency of site level documentation throughout the study
• May assist the project manager II with quality reviews and/or audits of the Trial Master File (TMF) to ensure inspection readiness
• May support clinical monitoring activities, such as CRA training, visit report review, site letters, and escalated site issues
• May track site qualification, initiation, routine and close‑out visits, project‑specific training, monitoring visit reports and follow‑up letters, compliance with monitoring plan, escalation of site‑related issues
• Maintains the project specific training matrix and confirms project team members are fully trained per the study matrix prior to performing study tasks
• Supports the sites and ensures that each site has the necessary material to adequately perform 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 resolution and data review process follow study timelines until database lock
• May provide technical, therapeutic and project management expertise in training and process improvement efforts for the department

Requirements

Ideal Profile

Education

• B.Sc. in a related field of study to clinical research

Experience

• 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 to clinical trial management

Knowledge And Skills

• 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
• Core Project Management competencies
• Demonstrated ability to establish and deliver resource‑based project plans
• Excellent people management skills; experience working with and managing teams in a matrix environment

Our Company

At 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 opportunities for advancement.

Work Location

The successful candidate for this position has the option to work remotely anywhere in Canada, or from our headquarters in Montreal, in accordance with company policies and public health directives. Occasional visits to our Montreal office may be required or encouraged.

Perks

• Flexible work schedule
• Permanent full‑time position
• Comprehensive benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development opportunities

About Indero

Indero is a contract research organization (CRO) specialized in clinical trials. Based in Montreal, we have built a strong reputation for the quality of our research and services that exceed client expectations. Indero continues to grow and expand across North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. Accommodations are available throughout the recruitment and selection process for applicants with disabilities upon request. Indero only accepts applicants who are legally authorized to work in Canada.