Description
Projects Managers are crucial to the success of Clinical Trials managed by Indero. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.
Great project managers go further than creating project plans and following up on tasks. They show leadership to help project teams focus on objectives and deliver results.
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 projects
- You are looking to position yourself in an environment where you can grow your career alongside the company
IMPACT AND RESPONSIBILITIES
Client interactions
- Serve as primary contact for the Sponsor
- Provide efficient and timely updates on trial progress
- Lead client calls effectively
Project 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.).
Quality and risk management
- Ensure 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.
Requirements
IDEAL PROFILE
Education
- B.Sc. in a relevant discipline
Experience
- At least 5 years of industry experience, including a minimum of 3 years leading multi-center clinical trials (phase II-III)
- Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD
- Experience managing dermatology trials
- Experience managing rheumatology trials an asset
Knowledge and skills
- Excellent knowledge of GCP and ICH standards, FDA and local country regulations
- Excellent knowledge of Microsoft Office suite
- Fluency in English with excellent oral and written skills, required
- Ability to work in a team environment and establish good relationships with colleagues and sponsors
- Good problem-solving abilities
- Strong ability to carry out different projects and work under pressure while meeting timelines
- 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. 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.