Julien Donnelier, M.Sc., Pmp Email & Phone Number

Calgary, Alberta, Canada

The Clinical Research Manager (CRM) at the Prostate Cancer Centre is an integral member of the research team and operations.- A key contact for the Southern Alberta Institute of Urology (SAIU) doctors, ethic’s boards, industry sponsors, and any other individuals who propose to conduct programs and research at the Centre. - Responsible for the oversight of all of the Centre’s research activities. - Ensures conduct of study protocols according to Good Clinical Practices (GCP) and site… Show more The Clinical Research Manager (CRM) at the Prostate Cancer Centre is an integral member of the research team and operations.- A key contact for the Southern Alberta Institute of Urology (SAIU) doctors, ethic’s boards, industry sponsors, and any other individuals who propose to conduct programs and research at the Centre. - Responsible for the oversight of all of the Centre’s research activities. - Ensures conduct of study protocols according to Good Clinical Practices (GCP) and site SOPs. - Responsible and accountable for managing clinical trial and data entry personnel, research laboratory staff, meeting financial budget goals, and overall operations of the clinical research department. Show less

Calgary, Alberta, Canada

The Manager of Clinical Trials is responsible for supporting all aspects of the clinical research process. This includes human resources management and deployment, and project management to ensure milestones are met and activities are completed according to the project timelines.- Responsible for all clinical trials organized out of the University of Calgary Stroke Program where the stroke program functions as the coordinating centre. Manage all aspects of clinical trials from protocol… Show more The Manager of Clinical Trials is responsible for supporting all aspects of the clinical research process. This includes human resources management and deployment, and project management to ensure milestones are met and activities are completed according to the project timelines.- Responsible for all clinical trials organized out of the University of Calgary Stroke Program where the stroke program functions as the coordinating centre. Manage all aspects of clinical trials from protocol and budget development, site contracts and regulatory management, to enrolment, monitoring and software/trial database integrations.- Develop and execute project plans, budgets, and associated documentation for clinical trials where the stroke program functions as the coordinating centre, managing full scope clinical trials, to enable research objectives to be realized.- Support in development of a standardized trial delivery model, documentation format for all group projects as well as support development of standards for the overall stroke clinical trial group operationsInteract and manage trial financial operations within the UofC accounting department on a per project basis. Show less

Calgary, Alberta, Canada

- Conducts site qualification, initiation, monitoring, and close-out visits for research sitesaccording to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines andapplicable regulations.- Participates in investigators’ meetings.- Prepares site visit reports and follow-up letters to the investigator.- Builds productive relationships with investigators and site staff to achieve study objectives,including patient recruitment targets.- Performs source… Show more - Conducts site qualification, initiation, monitoring, and close-out visits for research sitesaccording to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines andapplicable regulations.- Participates in investigators’ meetings.- Prepares site visit reports and follow-up letters to the investigator.- Builds productive relationships with investigators and site staff to achieve study objectives,including patient recruitment targets.- Performs source data verification, ensures on-site study drug storage, dispensing, andaccountability, data collection, and regulatory document collection is adequate. Show less

Calgary, Alberta, Canada

- Collaborates directly with the study teams, CRAs, external site staff, country ethicscommittees/IRB to ensure tasks and priorities are aligned to the defined study timelines.- Ensures investigator sites regulatory documentation is collected, reviewed, filed, and remainscurrent. Ensures the eTMF remains complete and contemporary.- Establishes site activation timelines with selected sites and coordinates activities to meetplanned activation timelines. Acts as a main point of… Show more - Collaborates directly with the study teams, CRAs, external site staff, country ethicscommittees/IRB to ensure tasks and priorities are aligned to the defined study timelines.- Ensures investigator sites regulatory documentation is collected, reviewed, filed, and remainscurrent. Ensures the eTMF remains complete and contemporary.- Establishes site activation timelines with selected sites and coordinates activities to meetplanned activation timelines. Acts as a main point of contact for all site correspondences fornon-protocol related issues. Show less

Calgary, Alberta, Canada

At the Dermatology Research Institute the Clinical Research Coordinator performs all clinical research activities from Feasibility Questionnaires to Study Close Out.• Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate (study start ups, ethics modifications, reportable events and renewals)• Perform delegated protocol specific activities completely and accurately for more than 30 clinical research studies (primarily… Show more At the Dermatology Research Institute the Clinical Research Coordinator performs all clinical research activities from Feasibility Questionnaires to Study Close Out.• Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate (study start ups, ethics modifications, reportable events and renewals)• Perform delegated protocol specific activities completely and accurately for more than 30 clinical research studies (primarily Psoriasis and Eczema, HS, Vitiligo and Alopecia).Screens, Informed Consents, visits as per protocol.Perform venipuncture and other biological sample collection, processing and shipment.Monitor and report all adverse experiences and abnormal results to the Investigator and SponsorMaintain and organize source documents, CRFs.Accurate and timely data entry in various EDC systems (MediData; Medrio; InForm; Customs; etc)Proficient use of several IWRS solutions to manage IMP (receipt, dispensation, change of status (Endpoint, Suvoda, Impala; etc)• Create source documents and any other research documents required for the successful conduct of a clinical research study.• Coordinate and attend SQVs, SIVs, IMVs, Investigator's meetings, site close out visits. Show less

Calgary, Canada Area

The Manager, Clinical and Regulatory Affairs is responsible for obtaining and maintaining worldwide marketing and clinical use permissions in a regulated environment. Working closely with the team members from the departments of product development, technology, operations, and sales & marketing, the Manager Regulatory Affairs performs all day-to-day tasks associated with filing and maintaining market clearance for new and existing products. In the role of Manager Clinical Affairs, the position… Show more The Manager, Clinical and Regulatory Affairs is responsible for obtaining and maintaining worldwide marketing and clinical use permissions in a regulated environment. Working closely with the team members from the departments of product development, technology, operations, and sales & marketing, the Manager Regulatory Affairs performs all day-to-day tasks associated with filing and maintaining market clearance for new and existing products. In the role of Manager Clinical Affairs, the position involves the management and conduct of Zephyr clinical investigations and participating in other research- and data-related activities of the Technology Department.RESPONSIBILITIES- Supports the planning, implementation, and development of regulatory strategies for products that require government approval.- Prepares and submits new applications for market authorization to the regulatory authorities- Monitors new regulations to assist in planning for changes impacting the Quality system and/or product.- Maintains device registrations, establishment registration, technical files, and device listings for all jurisdictions.- Acts as the chair of the Recall and Withdrawal Committee and leads investigations as required.- Manages all aspects of Unique Device Identification and medical device reporting.- Determines the need for, plans, prepares, and submits appropriate applications required for investigational testing.- Maintains and manages clinical trial data in compliance with the protocol and requirements of the regulatory bodies and ethics review board.- Ensures that clinical research and related activities are performed in accordance with Federal and regional regulations as well as those of Zephyr and co-sponsoring companies’ policies and procedures, including the maintenance of clinical trial registries and PHI. Show less

Calgary, Canada Area

Dept. of Psychiatry | Cumming School of Medicine | University of CalgaryMathison Centre for Mental Health Research & Education | Hotchkiss Brain InstituteDr. Jean M. Addington (www.jeanaddington.com)Responsible for the management of all of the research projects in the research group, oversees the development and management of a range of clinical research projects• Preparing research proposals for submission to granting agencies.• Development of consent forms and… Show more Dept. of Psychiatry | Cumming School of Medicine | University of CalgaryMathison Centre for Mental Health Research & Education | Hotchkiss Brain InstituteDr. Jean M. Addington (www.jeanaddington.com)Responsible for the management of all of the research projects in the research group, oversees the development and management of a range of clinical research projects• Preparing research proposals for submission to granting agencies.• Development of consent forms and ethics applications and maintaining ethical approval.• Managing the budgets of all ongoing research projects.• Developing, maintaining and monitoring training and reliability training for all clinical measures used in both onsite and multi-site projects.• Responsible for the development and maintenance of case report forms for all projects.• Working closely with data manager and all clinical raters.• Working with study coordinators at other sites for certain multi-site projects.• Developing the coordination of all new studies.• Conducting clinical assessments with research participants when necessary.• Collaborating with research team on development of new papers, publications and/or presentations. Show less

Clinical Research Unit

• Provided support for clients projects on:Protocol designIRB applicationSite operation workflowDrug workflowManagement of CT documentation CTMS on Confluence with version control + Trial Master File (project management software)Consultation for best statistical analysis planData Entry/Query and Data Quality Control• Provided data management design & implementation support on electronic platforms:Design and development of CRFs, eCRFs, data and safety… Show more • Provided support for clients projects on:Protocol designIRB applicationSite operation workflowDrug workflowManagement of CT documentation CTMS on Confluence with version control + Trial Master File (project management software)Consultation for best statistical analysis planData Entry/Query and Data Quality Control• Provided data management design & implementation support on electronic platforms:Design and development of CRFs, eCRFs, data and safety reportsREDCap, iDataFax, OpenClinica, & THIN for client research projects • Supported the various applications in clients’ projectsICH, GCP, HC & FDAInternal policiesIT and privacy officer (HIPAA) policies• Helped with the development of CRU policies, SOPs and working documents• Responsible for the development of training documentation for clients for training sessions:REDCapCDISC, CDASHCRFs design best practicesData query for CRAs on iDataFax platform• Client project intakeEvaluated the status of CT. Suggested options for next steps with associated budget planManaged the option chosen with client and internal team members Show less

Clinical Research Unit

The research coordinator works with and under the direction of the Project Manager and with clients of the Clinical Research Unit. He provides methodological and project execution support and study design to principal investigators of clinical trials. He helps ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agencies policies and procedure.

University Of Calgary

Medical Science Graduate Education- Acquired extensive knowledge and experience in molecular and cellular biology and neuroscience, characterizing several lysosomal proteins level in mouse neurodegeneration.- Communicated research results with clarity at laboratory meetings and conferences in Canada and abroad. Wrote and first authored peer reviewed papers.- Trained new students ensuring that they understand best practices related to research.

Master'S Degree, Medical Science

Bachelor'S Degree, Cellular Biology And Physiology