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Clinical data management Jobs in Levis, QC

Last updated: 16 hours ago
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Clinical Trial Manager II -Canada

Clinical Trial Manager II -Canada

Syneos HealthQuebec City, QC, Canada
Full-time
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into...Show moreLast updated: 16 hours ago
  • Promoted
  • New!
Asset management Manager

Asset management Manager

Administration portuaire de QuébecQuebec City, QC, Canada
Full-time
From here, you can see far ahead!".The Port of Quebec's vision? To be a Port recognized by citizens for its responsible management of the territory, respect for the environment and protection of bi...Show moreLast updated: 16 hours ago
  • Promoted
Quebec Cardiac Valves sales

Quebec Cardiac Valves sales

MoreauGrant Consulting IncQuebec, Canada
Full-time
The Territory Manager, Quebec will provide excellent sales and service to end users supporting cardiac surgery and complimentary products. Responsible for projecting and achieving sales targets in u...Show moreLast updated: 1 day ago
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Site Monitor II

Site Monitor II

ParexelQuebec, Canada
Full-time
Bilingual- English / French proficiency.The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with International Council for Harmonization and Good Clinical Pr...Show moreLast updated: 1 day ago
General Management Assistant

General Management Assistant

DesjardinsQuébec
CA$26.41–CA$28.85 hourly
Full-time
The incumbent supports the general manager and all managers of a medium-sized caisse in carrying out various administrative support and secretarial tasks. Activities include assisting with the plann...Show moreLast updated: 30+ days ago
  • Promoted
Change Management Specialist

Change Management Specialist

MytechtalQuebec City, Quebec, Canada
We are seeking an experienced and dynamic Organizational Change Management.OCM) Lead for one of our clients to join to their IT organization. The OCM lead requires a deep and broad knowledge of chan...Show moreLast updated: 24 days ago
Sales Account Management

Sales Account Management

EightSix NetworkQC
CA$24.16 hourly
Inside salesOsela is a specialist manufacturer of laser illumination systems and structured lighting for machine vision applications requiring precise laser beam shaping, as well as for research an...Show moreLast updated: 30+ days ago
Premium Management Technician

Premium Management Technician

CIE_101 Beneva Inc.Quebec, Quebec
CA$40,000.00–CA$45,000.00 yearly
Full-time
En tant que technicien(-ne) en administration bilingue, vous effectuez les tâches reliées à l’aspect financier de l’administration des contrats d'assurance collective. Vous vous réalisez dans les fo...Show moreLast updated: 30+ days ago
Change Management Specialist

Change Management Specialist

Bank of CanadaOttawa or Calgary, QC, CA
CA$108,874.00–CA$128,087.00 yearly
Full-time
The Bank of Canada has a vision to be a leading central bank—dynamic, engaged and trusted—committed to a better Canada.No other employer in the country offers you the unique opportunity to work at ...Show moreLast updated: 10 days ago
Change Management Trainer

Change Management Trainer

PVA Consulting Group, QC, Canada
CA$70.00–CA$75.00 hourly
Show moreLast updated: 30+ days ago
Crisis Management Broker

Crisis Management Broker

AonQuebec, Canada
CA$100,000.00 yearly
Are you curious by nature? Interested in news and what is going on around the globe? Make a difference for a customer drives you? Do you like being part of THE team in the market? If so, this oppor...Show moreLast updated: 30+ days ago
  • Promoted
Data Entry Clerk (Remote)

Data Entry Clerk (Remote)

ApexFocusGroupLévis, QC, Canada
CA$850.00 weekly
Remote
Full-time +1
Now accepting applicants for Focus Group studies.Earn up to $850 per week part-time working from home.Must register to see if you qualify. No Data Entry experience needed.Data Entry Clerk Work From ...Show moreLast updated: 2 days ago
  • Promoted
SAP Data Lead

SAP Data Lead

PrecisionERP IncorporatedGreater Montreal Metropolitan Area, Canada
Full-time
Location : Montreal preferred but Oakville possible.Hybrid – 2 days per week onsite.The individual will be a Lead for all data migration, conversion, aligning activities for a greenfield SAP S4 Hana...Show moreLast updated: 1 day ago
Analyst, Workforce Management

Analyst, Workforce Management

Intact Financial CorporationQuébec, Quebec, Canada
Full-time
We are looking for a Workforce management Analyst to join our growing team!.Our primary focus is on the outperformance and growth of our agencies and external partners with whom we cultivate and nu...Show moreLast updated: 13 days ago
Data Architect

Data Architect

Tundra Talent CommunityQuébec City, QC, Canada (On-site)
CA$40.00–CA$75.00 hourly
Description du mandat / Mandate description : .We are looking for a Data Architect to help govern and define how IFC manages and shares critical information assets. Specifically, we are looking for a ...Show moreLast updated: 30+ days ago
Coordinator, Emergency Management

Coordinator, Emergency Management

Canadian Red CrossCAN - AB - Province
CA$47,922.00–CA$59,903.00 yearly
Coordinator, Emergency Management.The Canadian Red Cross (CRC) – an inspirational not for profit organization, helps people and communities in Canada and around the world in times of need and suppo...Show moreLast updated: 30+ days ago
Data Specialist

Data Specialist

LeddarTechQuébec, Quebec, Canada
CA$85,000.00 yearly
Improve the data lifecycle (40%).Study and assess current data infrastructure and propose a plan to integrate current systems to a desired future state based on LeddarTech business vision.Provide r...Show moreLast updated: 30+ days ago
Clinical Project Coordinator

Clinical Project Coordinator

AlimentivQuebec City, Quebec, ,
Full-time
Provide administrative, clerical, implementation and / or processing support to the project teams and stakeholders.Assist with document / process / report development, testing, tracking, distribution, an...Show moreLast updated: 8 days ago
Data Warehouse Project Management Consultant

Data Warehouse Project Management Consultant

ITIQuébec
CA$80,000.00 yearly
Nous mettons à profit l’intelligence humaine, organisationnelle, opérationnelle, pas juste artificielle.Établie depuis 1991, ITI offre des services et solutions technologiques allant du conseil str...Show moreLast updated: 30+ days ago
Clinical Trial Manager II -Canada

Clinical Trial Manager II -Canada

Syneos HealthQuebec City, QC, Canada
16 hours ago
Job type
  • Full-time
Job description

Description

Clinical Trial Manager

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities

  • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol / GCP / regulatory compliance and data integrity.
  • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.
  • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
  • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs / Central Monitors) is aware of the contractual obligations and parameters.
  • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
  • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
  • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
  • Participates and presents in key meetings such as Kick Off Meeting.
  • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.
  • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
  • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.
  • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
  • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
  • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
  • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS / IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits / calls, duration, and frequency) according to plan.
  • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP / SMP, and risk plans.
  • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol / GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and / or sponsor specifications, including delivery deadlines.
  • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management.
  • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope.
  • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines.
  • Provides feedback to line managers on staff performance including strengths as well as areas for development.
  • Qualifications

    What we’re looking for

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Ability to lead and align teams in the achievement of project milestones
  • Capable of working in an international environment
  • Previous clinical trial experience in site management
  • Preferred experience with risk-based monitoring and clinical or central monitoring
  • Familiar with financial principles and budget management practices
  • Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills
  • Good communication, presentation and interpersonal skills among project team and with sites
  • Basic conflict resolution skills
  • Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
  • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
  • Moderate travel may be required, approximately 20%
  • Get to know Syneos Health

  • Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
  • No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

    Additional Information :

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.