Clinical Data Manager ofertas em United States

Division: Pharma - Clinical Research

We are looking for an experienced Clinical Data Manager to support ongoing growth in our Data Management department. The role can be remote (home-based) anywhere within Canada.

The Clinical Data Manager will perform data management activities at all stages of assigned projects such as start-up (CRF design, EDC build & validation, training, DM planning), execution (data cleaning, metrics tracking, running listings, SAE reconciliation, medical coding, document management) and closeout (database lock and data transfer).

• Are you a team player striving for continuous improvement?
• Are you driven by high quality clinical data and ensuring excellent service to your customers?
• Do you enjoy being faced with a challenge and troubleshooting innovative solutions?
• Are you flexible and able to adapt to an evolving and dynamic work environment?
• Are you interested in exposure to other functional areas, to better understand how your role fits into the bigger picture?
• Do you want to make an impact and be recognized for your contributions?

If you have answered YES, we encourage you to apply!

• Provide data management expertise to both internal and external stakeholders
• Data Management project planning and risk management
• Create and implement Data Management Plans that will ensure delivery of quality clinical data in a timely and efficient manner (developed in collaboration with the Clinical Study Manager)
• Develop Case Report Forms (CRFs), EDC database design and annotate CRFs
• Create and test system edit & data validation checks, oversee User Acceptance Testing
• Generate CRF completion Guidelines (CCGs), and deliver EDC training as needed
• Identify potential data management issues, initiate preventative measures, and escalate issues appropriately.
• Collaborate with cross-functional study team members (clinical operations, biostatistics, drug safety, etc.) to define the necessary listings needed for the support of clean-up, validity, and summary tables
• Run SAS programs to generate complex listings, tables and complex graphs
• Data cleaning and discrepancy management.
• Medical coding (with oversight by medical monitor)
• Track and report on metrics, status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
• Oversee the freezing and locking of data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock
• Accountable for the high-quality output on assigned data management deliverables as per the established timelines.
• Carry out assigned data management activities in strict compliance with applicable study plans, SOPs, regulatory and GCP standards.
• Actively participate in the generation and/or review of relevant SOPs & working instructions
• Recommend and drive continuous improvement of processes, systems and tools to enhance the data management function and increase efficiency
• Implementation of global standards related to clinical study data management activities.
• Participate and/or complete internal and external training within specified timelines
• Support achievement of data management revenue and gross margin targets
• Develop and maintain strategic client relationships
• Support proposal development with data management time and cost estimates and prepare and present to potential clients on data management capabilities
• Fulfill other duties as required

Competencies:

• In-depth knowledge of ICH-GCP guidelines and applicable regulations
• Ability to communicate complex data management concepts to non-data managers
• Understanding of CDISC, CDASH, SDTM, ADaM, XML
• Meticulous, high level of attention to detail, autonomous and able to work with minimal supervision
• People management skills (collaborative, positive, empathy)
• Project management skills & financial acumen with respect to managing study budgets
• Effective time management skills and ability to manage competing priorities
• Customer focused, analytical and a problem solver
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Proficiency in Microsoft Office applications, specifically Word, Excel, PowerPoint and Outlook
• Previous experience in the implementation of global standards related to clinical study data management activities preferred
• Strong English communication skills (oral, written and presentation), French is an asset
• Proficiency with iMedNet (asset)
• SAS programming (asset)

• Undergraduate university degree (science or related major preferred), relevant work experience may be considered as equivalent qualification.
• A minimum of five (5) years of pharmaceutical or CRO experience, including two (2) or more years specifically in clinical data management.