fbpx

Senior Project Manager


Senior Projects Managers are crucial to the success of Clinical Trials managed by Innovaderm. 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 Canadian-owned 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
  • You are recognized for your team leadership and ability to 

 

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.  

IDEAL PROFILE

 

Education 

  • B.Sc. in a related field of study to clinical research;
  • PMP certification is an asset

 

Experience 

  • At least 10 years industry experience including a minimum of 3 years in a CRO;
  • At least 7 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) 
  • Experience leading multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
  • Experience in one or more of the following considered an asset: study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management;
  • Therapeutic experience managing dermatology, onco-dermatology, inflammatory bowel diseases, rheumatoid arthritis or oncology 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
  • Bilingualism (English and local language) is an asset
  • 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 Innovaderm, 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. 

 

In this position, you will be eligible for the following perks: 

  • Flexible work schedule 
  • Permanent full-time position 
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, social activities) 
  • Ongoing learning and development 

 

About Innovaderm  

Innovaderm 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, Innovaderm continues to grow and expand in North America and Europe. 

 

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

Innovaderm only accepts applicants who can legally work in Canada. 

All Available Positions


Position Department Location
Team Leader Administration Corporate - IT and Support Services Montréal, Canada
Clinical Research Associate (CRA), Dermatology, USA North Est Region CRO - Clinical Monitoring Remote, USA North Est region
Clinical Research Associate (CRA) - North Ouest CRO - Clinical Monitoring USA - North West
SAS Programmer CRO - Biometrics Canada
Senior Statistical SAS Programmer CRO - Biometrics Canada
Clinical Data Coordinator CRO - Biometrics Canada
Clinical Data Manager CRO - Biometrics Canada
EDC Clinical Study Builder CRO - Biometrics India
Senior Biostatistician CRO - Biometrics Canada
Senior Biostatistician (India) CRO - Biometrics India
Regulatory Documents Assistant (eTMF)  CRO - Scientific and Regulatory Affairs Canada
Associate TMF Operations CRO - Scientific and Regulatory Affairs Canada
Regulatory Affairs Coordinator CRO - Scientific and Regulatory Affairs Montréal, Canada
Regulatory Affairs Specialist CRO - Scientific and Regulatory Affairs Poland
Senior Project Manager CRO - Project Management Canada
Patient Recruitment and Advertisement Manager CRO - Project Management Remote, Canada
Clinical systems specialist CRO - Project Management Remote, Canada
Site Budget and Contract Specialist CRO - Project Management Canada
Senior Project Coordinator (Clinical Research) CRO - Project Management Canada
Project Coordinator (Clinical Research) CRO - Project Management Canada
Clinical Research Associate (CRA), Dermatology CRO - Clinical Monitoring Remote, Canada
Clinical Research Associate (CRA), Dermatology CRO - Clinical Monitoring Remote, Canada
Senior Clinical Research Associate CRO - Clinical Monitoring Poland
CRA Manager CRO - Clinical Monitoring Montreal, Canada
Patient Recruitment Auxiliary Nurse Clinical Research Unit Montreal, Canada
Clinical Research Auxiliary Nurse Clinical Research Unit Montreal, Canada
Proposal and Contract Manager Corporate - Business Development and Marketing Canada
Vice President, Business Development and Marketing Corporate - Business Development and Marketing Canada or USA
Process Improvement Specialist Corporate - IT and Support Services Canada
Accounts Receivable Technician Corporate - Accounting and finance Montreal, Canada
Future opportunities General Montreal, Canada