Clinical Data Manager Ii

4 days ago

Toronto, Canada Allucent Full time

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Clinical Data Manager II (DM II) to join our A-team (hybrid*/remote). As a Clinical DM II at Allucent, you will assist in data management related activities of the Allucent Data Management (DM) department. This position supports and performs DM-related activities from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting..

**In this role your key tasks will include**:

- Assist in DM-related tasks and collaborate with Lead DMs and relevant roles within Data Management (e.g. Clinical Programmers, Data Scientists).
- May act as primary contact for DM with all relevant parties, both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Biostatistics and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
- Provide feedback and status updates to Lead DM regarding progress, timelines, risk and quality and plan and when assigned as lead CDM, project resources based on assigned tasks and projects
- Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests
- Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements
- Provide support during clinical study database set-up, including eCRF design and database validation requirement and may lead these activities
- Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan)
- Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
- Create training materials for EDC users and provide project-specific training as required
- Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
- Participate in creating data cleaning strategy in consultation with applicable functional groups and assist in data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
- Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
- Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance
- Support and conduct Quality Review checks during study. May organize and lead Quality Review activities on behalf of lead DM.
- Support and/or manage the database maintenance, lock and close-out processes and procedure
- May participate in conference calls and/or meetings with vendors and sponsors
- Recognize and solve potential problems and evaluate effectiveness
- Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
- Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
- Help to align data management and clinical programming best practices, standards and conventions within the company
- Propose and support initiatives for improving efficiency
- Actively support to staff learning & development within the company
- Share relevant information at applicable DM departmental meetings
- Contribute in the field of Clinical Data Management activities to the evaluation/improvement of processes and procedures within the Quality Management System
- Assure good communication and relationships with (future) clients
- Contribute to other areas of business as required

**Requirements**:
**To be successful you will possess**:

- Bachelor's degree in Life sciences
- Post Graduate degree from local university
- 5+ years of relevant work experience as Clinical Data Manager
- 5+ years of experience in drug development and/or clinical research
- 5+ years of EDC experience in Medidata Rave, Merative/Zelta-IBM)
- Clinical trial data experience specializing in various therapeutic areas such as: oncology, autoimmune, immunology, hematology, rare diseases, etc.
- Good knowledge of ICH-GCP, GDPR/HIPPA and applicable (local) regulatory requirements
- Good understanding of Medical Terminology
- Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, familiar with IRT and eCOA
- Active participation and support in Data Management activities related to database setup, data cleaning and query management, external data reconciliation for at least 3 studies.
- Good understanding of relational database components and experience in tech

  • Senior Clinical Data Manager Lead

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services IncWe are seeking an experienced Clinical Data Manager to join our team in Toronto/Markham, Ontario, Canada.About UsEverest Clinical Research is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to pharmaceutical, biotechnology, and medical device...

  • Clinical Data Team Lead

    6 months ago

    Toronto, Canada WEP Clinical Full time

    Exciting Opportunity: Clinical Data Team Lead (WEP Clinical) Do you want to be a part of a team that gives hope to patients living with rare and life-threatening diseases? Are you looking for career growth, challenges, or simply a more motivating role? At WEP Clinical, our business is growing and the career opportunities are endless. Our team member’s...

  • Clinical Data Management

    2 weeks ago

    Toronto, Canada Bio Pharma Services Full time

    Clinical Data Manager Position Summary: The Clinical Data Manager is responsible for the set up and management of the clinical study database, the collection and quality of the clinical study data and the preparation of the clinical data to current regulatory and industry expectations and standards. Duties and Responsibilities: - Independently perform all...

  • Data Management Specialist

    4 days ago

    Toronto, Ontario, Canada Allucent Full time

    Company OverviewAllucent is a dynamic company dedicated to assisting small-medium biopharmaceutical companies in navigating the complexities of clinical trials. Our goal is to bring life-changing therapies to patients worldwide.Job DescriptionWe are seeking a skilled Clinical Data Manager II to join our A-team (hybrid/remote). As a Clinical DM II at...

  • Senior Clinical Data Management Professional

    3 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Data Management Professional to join our team at Everest Clinical Research Services Inc.

  • Clinical Data Specialist

    2 weeks ago

    Toronto, Canada Healwell AI Inc Full time

    Clinical Data Specialist Position Summary: The Clinical Data Specialist, working with senior data management members, is responsible for the setup, documentation, implementation and locking of clinical study databases and clinical data for clinical studies to current regulatory and industry expectations and standards. Duties and Responsibilities: -...

  • Senior Clinical Data Management Director

    3 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    About UsEverest Clinical Research Services Inc. is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries.Salary and BenefitsWe offer a competitive salary of approximately $185,000 per annum, plus benefits that include health insurance, retirement...

  • Clinical Study Assistant Ii Ahrc Obs Research Unit

    7 months ago

    Toronto, Canada Unity Health Toronto Full time

    The Applied Health Research Centre (AHRC) at St. Michael¿s Hospital is currently seeking a Clinical Study Assistant II. The Clinical Study Assistant II will report directly to the Manager, Observational Epidemiology and Qualitative Research Unit (OEQRU), and will support research studies managed by the OEQRU. The primary role of the Clinical Study...

  • Clinical Trials IWRS Data Management Specialist

    3 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services IncWe are a full-service contract research organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries worldwide.Job Description:As a Clinical Trials IWRS Data Management Specialist, you will be responsible for ensuring the accuracy...

  • Clinical Data Analyst Lead

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    About the RoleWe are seeking a skilled Clinical Data Analyst Lead to join our team at Everest Clinical Research Services Inc. This is a fantastic opportunity for an experienced professional to lead clinical data analysis projects and collaborate with cross-functional teams.

  • Clinical Research Coordinator

    6 months ago

    Toronto, Canada Clinical Research Full time

    Responsibilities: - Coordinate and oversee clinical research studies from start to finish - Collect and record data accurately and efficiently - Analyze research data and prepare reports for review - Ensure compliance with study protocols, regulations, and ethical guidelines - Collaborate with healthcare professionals, researchers, and study participants -...

  • Clinical Research Associate Ii

    6 months ago

    Toronto, Canada Sunnybrook Health Sciences Centre Full time

    The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institute’s (SRI) ongoing commitment to participate in innovative and high quality clinical research. Within OCC Clinical Research, the Research and Medical Directors, Quality Assurance and Education Manager, Operations Assistant Manager and Budget & Operations...

  • Client Delivery Executive Ii

    6 months ago

    Toronto, Canada NTT DATA Full time

    **Req ID**: 275012 We are currently seeking a Client Delivery Executive II - Hybrid in Port Elgin, Ontario to join our team in Port Elgin, Ontario (CA-ON), Canada (CA). **This is a hybrid position in the Port Elgin, Ontario location. This CDE must be willing to work onsite at the client's office most days of the week. If you are not local to the area,...

  • Senior Clinical Data Lead, Biostatistics

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    About Everest Clinical Research Services IncLocation: Bridgewater, New Jersey, USA (on-site) or Remote within the USA (in accordance with our Work from Home policy)Job Title: Senior Clinical Data Lead, Biostatistics

  • Clinical Development Specialist II with Rare Disease Expertise

    3 weeks ago

    Toronto, Ontario, Canada Veristat Full time

    Veristat's Clinical Development Team: A Hub for Rare Disease InnovationWe are seeking a skilled Clinical Development Specialist II to join our team, leveraging your expertise in clinical development and rare diseases. This role offers an exciting opportunity to collaborate with global experts in the field.About VeristatFor over 27 years, Veristat has...

  • Clinical Trials Coordinator Lead

    3 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc, a leading contract research organization (CRO), is seeking an experienced Clinical Trials Coordinator Lead to join our team in Toronto/Markham, Ontario, Canada.Job Summary:As a Clinical Trials Coordinator Lead, you will be responsible for providing exceptional support to clients and internal teams in the delivery of...

  • Data Analyst II

    3 weeks ago

    Toronto, Canada Quantum Management Services Ltd. Full time

    Position: Data Analyst II Location: Toronto (Remote) Job Type: 12-month contract (potential for extension) Hours: Monday to Friday, 9 a.m. to 5 p.m., 37.5 hours per week We are searching for a Data Analyst II to join our client's team. Responsibilities: - Assess/query large datasets to determine impactful trends within our business - Interpret data...

  • Clinical Development Manager

    3 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    About UsEverest Clinical Research Services Inc is a renowned contract research organization (CRO) that provides comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries globally. Established in 2004, our company has evolved from a statistical and data management center of excellence to a full-service CRO with...

  • Data Analyst II

    3 weeks ago

    Toronto, Canada Quantum Management Services Ltd. Full time

    Position: Data Analyst IILocation: Toronto (Remote)Job Type: 12-month contract (potential for extension) Hours: Monday to Friday, 9 a.m. to 5 p.m., 37.5 hours per week We are searching for a Data Analyst II to join our client's team.Responsibilities: - Assess/query large datasets to determine impactful trends within our business- Interpret data trends and...

  • Data Analyst II

    3 weeks ago

    Toronto, Canada Quantum Management Services Ltd. Full time

    Position: Data Analyst IILocation: Toronto (Remote)Job Type: 12-month contract (potential for extension) Hours: Monday to Friday, 9 a.m. to 5 p.m., 37.5 hours per week We are searching for a Data Analyst II to join our client's team.Responsibilities: - Assess/query large datasets to determine impactful trends within our business- Interpret data trends and...