Prometic BioSciences Inc. develops unique innovative therapeutics, orally active compounds that target multiple uncovered medical needs in the fields of hematology, oncology, nephrology, fibrosis and autoimmune diseases.
The department of Clinical Affairs of Prometic BioSciences is seeking a Manager, Clinical Data Management, to work with its team in Laval, Quebec. Reporting to the Director, Clinical Affairs, the incumbent will lead the data management activities at Prometic. They will be responsible for overseeing and supporting Prometic clinical trials and ensuring that data management objectives are met in accordance with clinical timelines and requirements. The incumbent will be responsible for the complete data management process, from study set-up to closeout, for individual protocols throughout the course of the study, and act as the primary contact on all data management study-specific issues. They will organize the cleaning efforts with the internal or external study team and participate in data cleaning. They will act as an internal consultant for clinical data management tools, standards and practices.
The Manager, Clinical Data Management, responsibilities will include:
- Work with cross-functional study team, third-party CROs and other data management staff on the:
- development of Data Management Plan (DMP), CRFs annotation and completion guidelines (CCG);
- design and test of databases;
- development of edit-check specifications;
- performance or management of query generation and resolution;
- performance or management of internal data review plans, study metrics reports, SAE reconciliation plans and medical coding plans (as applicable);
- reconciliation of CRF SAE data with safety data (pharmacovigilance);
- development of protocol deviations specifications document, with input from the study team (i.e. Project leaders).
- Design data management metrics and effectively utilize metrics reports within EDC systems to ensure effective and efficient clinical data management contribution to the clinical study team against defined project timelines and priorities.
- Work with SAS programmers and/or CRO on regular/ad hoc listing/patient profile generation/review to ensure quality clinical data management deliverables.
- Work with line management and clinical team on the:
- development of optimal resourcing model, processes and work flows for database set-up, data capturing and cleaning, internal and external validation, database lock and archiving, etc.
- selection and oversight of vendors/CROs for Data Management, EDC, IVRS, and ePRO, as appropriate, to ensure quality of product.
- Develop or contribute to the development of data management SOPs, the development and accumulation of data management standards, work modules, and reusable tools; ensure compliance with ICH, GCP, regulatory and internal requirements.
- Supervise, coach and develop clinical data management professionals (internal and/or outsourced) on study procedures, handling and management of trial data.
- Lead and participate in user acceptance testing (UAT) of the clinical database and programmed edit checks.
- Define/oversee data transfer specifications for external data sources (central labs, ECGs, PK) and transfer of data; integrate and reconcile external electronic data with clinical database.
- Generate specifications for internal study team data review listings.
- Lead internal study team in data review; perform data review for quality issues and general data trends; generate and review queries as necessary.
- Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures and medications.
- Train clinical trial sites staff and CRAs on data flow and quality control processes.
- Validate and distribute study progress status reports to internal and external study team members.
- May provide input to protocols, and other clinical study documents during development
- May participate in review of proposals, budgets, and scopes of work related to outsourced data management activities.
The selected candidate will hold a BSc in the Health Sciences or Quantitative fields, with seven (7) years of experience in clinical data management, in the pharmaceutical/biotechnology industry, including two (2) years of vendor management experience. A comprehensive understanding of GCP/ICH standards, FDA regulations, as applicable to data management, is also sought, as well as knowledge of CDM systems, Working Practices and relevant Clinical Operations SOPs, Clinical Data Interchange Standards Consortium/Study Data Tabulation Model (CDISC/SDTM) and clinical data coding principles. The incumbent should possess data review hands-on experience with database design and concepts, and experience in conducting trials using Electronic Data Capture (EDC), IVRS, and ePRO. Experience training and presenting at Investigator Meetings is required as well, together with familiarity with MedDRA and WHO-Drug dictionaries. Knowledge of SAS or other relevant programming skills are strongly recommended.
The following criteria are required as well:
- Strong leadership in clinical data management activities and a desire to excel in leading data management projects.
- Demonstrated ability to operate independently and to influence decision-making processes within a matrix team environment.
- Strong initiative in identifying issues and proposing solutions with ongoing studies, a good investigative and meticulous approach to all activities and tasks.
- Experience using metrics to monitor internal/external quality and activities.
- Leadership, interpersonal and organizational skills, and excellent communication and facilitation skills.
- Ability to use various data review tools and methods is preferred.
- Experience in management of consultants and direct reports is a plus.
Prometic offers a competitive compensation, comprehensive benefits program, a flexible work schedule and a casual working environment.
To apply, please send a cover letter and copy of your resume to hr with the following reference: PBI-Med-1701. Prometic is an equal opportunity employer. Only chosen candidates will be contacted for an interview. For more information about Prometic, visit our website www.Prometic.com.