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Full-time
bachelor degree, postgraduate degree, professional certificate
Advancement Opportunities
Posted 17d ago
~40 hrs/week
Remote in Germany
Responsibilities
Oversees a portfolio of clinical studies in dermatology and rheumatology, managing Project Managers and ensuring adherence to quality standards and regulatory requirements. Leads operational contributions to business development, proposal pricing, and client relationship management.
Requirements
Requires at least 10 years of clinical project management experience and 15 years of industry experience, specifically within a CRO. Must have a background in dermatology or rheumatology trials and a Bachelor of Science degree.
Full job description
The Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same therapeutic area or indication for more than one customer. The Project Director oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects. The Project Director leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise
This role will be perfect for you if:
You are looking to contribute your expertise to the growth of a specialized CRO
You are a hands-on leader
You have at least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management.
You have experience in dermatology or rheumatology trials is required
RESPONSIBILITIES
Oversees a portfolio or program of projects and the Project Managers assigned to operationalize the awarded studies.
Ensures all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
Represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations.
Oversees the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
Ensures and maintains an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
Applies study specific learning across assigned portfolio of studies/clients.
Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
May lead operational input to proposal development and pricing including proposed operations strategy
Drives performance improvement, operational efficiencies and innovative strategies
May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert
Requirements
IDEAL PROFILE
Education
Bachelor of Science in a relevant discipline.
A Master’s degree is an asset.
PMP or PRINCE2 Certification is an asset
Experience
At least 15 years industry experience and a minimum of 5 years at a CRO
At least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable.
Experience leading concurrent multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
Substantial experience in project supervision, mentoring and coaching project managers
Substantial experience with business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like
Participation in mentoring and coaching of a representative number of project managers
Dermatology or rheumatology experience is required
Knowledge and skills
Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
Our company
The work environment
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 advancement opportunities.
Work location
Note that this opening is for a home-based position in Germany
Regular travel, which may include overnight trips and / or international travel is required as part of this role.
About Indero
Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
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 Germany.
All in with your dermatology & rheumatology clinical development
Industry
Research Services
Company size
201-500 employees
Founded
2000
Headquarters
Montreal, Quebec
LinkedIn followers
33,752
Indero: Your Dual-Focus CRO for Dermatology & Rheumatology
At Indero, we specialize in providing comprehensive Contract Research Organization (CRO) services for dermatology and rheumatology. Our team feels like an extension of your own, offering scientific guidance, accurate results, and exceptional customer satisfaction.
Our Expertise: With over 25 years of deep medical and operational expertise in dermatology, we seamlessly translate our knowledge to rheumatology. We understand that dermatology and rheumatology are inextricably linked, as immune-mediated inflammatory skin and joint diseases often require similar treatments.
Our Services: We set the standard with our value-added services, including:
• Study Design and Protocol Development
• Regulatory Submissions and Consulting
• Trial Master Files Management
• Project Management
• Investigator/Site Selection
• Patient Recruitment
• Clinical and Medical Monitoring
• Pharmacovigilance
• Data Management and Biostatistical Analysis
• Clinical Study Reports and Medical Writing
Since 2000, Indero has built a strong reputation for the quality of our research and the care we offer to study participants, clients, and sites. We often exceed our clients' timeline expectations, ensuring successful outcomes for every project.
Offices: 3530 Boulevard St-Laurent, Suite 300, Montreal, Quebec H2X 2V1, CA
DermatologyPhase I to IV clinical trialsClinical Research SiteClinical ResearchFull service CRORheumatologyRegulatory Consultingand BiometricsProduct ResearchMedical
All in with your dermatology & rheumatology clinical development
Industry
Research Services
Company size
201-500 employees
Founded
2000
Headquarters
Montreal, Quebec
LinkedIn followers
33,752
Indero: Your Dual-Focus CRO for Dermatology & Rheumatology
At Indero, we specialize in providing comprehensive Contract Research Organization (CRO) services for dermatology and rheumatology. Our team feels like an extension of your own, offering scientific guidance, accurate results, and exceptional customer satisfaction.
Our Expertise: With over 25 years of deep medical and operational expertise in dermatology, we seamlessly translate our knowledge to rheumatology. We understand that dermatology and rheumatology are inextricably linked, as immune-mediated inflammatory skin and joint diseases often require similar treatments.
Our Services: We set the standard with our value-added services, including:
• Study Design and Protocol Development
• Regulatory Submissions and Consulting
• Trial Master Files Management
• Project Management
• Investigator/Site Selection
• Patient Recruitment
• Clinical and Medical Monitoring
• Pharmacovigilance
• Data Management and Biostatistical Analysis
• Clinical Study Reports and Medical Writing
Since 2000, Indero has built a strong reputation for the quality of our research and the care we offer to study participants, clients, and sites. We often exceed our clients' timeline expectations, ensuring successful outcomes for every project.
Offices: 3530 Boulevard St-Laurent, Suite 300, Montreal, Quebec H2X 2V1, CA
DermatologyPhase I to IV clinical trialsClinical Research SiteClinical ResearchFull service CRORheumatologyRegulatory Consultingand BiometricsProduct ResearchMedical