• Monitor study status (ie. enrollment, CRFs monitored/approved, etc.) on an ongoing basis

• Present deliverables to clients, gather feedback and propose solutions.

• Provide regular data status reports to the project team

• Oversee work of the Clinical Data Coordinator as required (quality, timeliness)

• Oversee vendors to ensure that timelines and deliverables meet sponsor and protocol requirements

• Is responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/close.

• Conduct reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/SAE (Serious adverse events) data

• Develop the data management plan (DMP)

• Build a study-specific clinical database using the EDC system:

• Design the electronic case report form (eCRF)

• Build the clinical database in the chosen EDC independently or with the support of an EDC programmer (determined based on the complexity of the system and study.

• Coordinate the validation and testing (UAT) of the clinical database

• Support the study team with the development of external systems capturing clinical data (ePRO or IWRS), ensuring that any data transfer requirements between these systems and the EDC are documented and tested appropriately.

• Develop eCRF completion guidelines and other training material

• Conducts training for site users/monitors on the clinical database

• Activate/de-activate new users in the clinical database in response to requests from the project manager and maintain records of such request

• Respond to users requiring assistance with the EDC system

• Generate data listings and reports needed for data review in preparation for database close/lock

• Ensure that data management documentation is complete and up to date in the trial master file (TMF)

• Archive the clinical database and related documents

• B.Sc. or M.Sc, or in a related field of study

• 10 years of clinical data management experience in the pharmaceutical industry or in a CRO environment

• 5 years of experience as a lead data manager

• Extensive experience working with EDC systems (experience with Medrio and Medidata Rave preferred)

• Highly organized and detail-oriented

• Project planning and time management skills

• Strong verbal and written communication skills in English

• Understanding of the drug development process and of applicable regulations, including Good Clinical Practices (GCP), ICH Guidelines

• Good understanding of CDISC SDTM/CDASH standards

• Knowledge of MedDRA and WHODrug dictionaries, an asset