Clinical Data Manager II (Canada)

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 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 technical data management practices (validation plans, testing, and documentation
• Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models
• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Administrative excellence
• Eye for detail, strong technical, analytical and problem-solving skills
• Good project management skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Ability to simplify complex issues into understandable concepts

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”