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Manager Data Management


The person holding this position will be responsible for delivering data management services to clients and project teams, by management of internal clinical data management staff. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’s commitment to sponsor’s requirements and timelines.

 

This role will be perfect for you if:

  • You want to start or continue to develop as a leader within a Data Management Team
  • You bring a mix of strong technical abilities and excellent interpersonal skills  
  • You wish to develop your career within a growing CRO based in Canada.  

 

 

RESPONSIBILITIES

 

  • Provides direct oversight of data management operations, including planning and assigning work, overseeing the performance of direct reports and conducting performance reviews.
  • Ensures adequate training and mentoring of data management personnel regarding applicable regulatory guidelines, data management practices, and computer systems.
  • Responsible for resource allocation in the department.
  • Maintains optimal department processes and implements excellent project-specific strategies.
  • Assists with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs.
  • Provides general data management support to the project team, sponsor and external vendors, as needed.
  • Is responsible for the development of electronic case report form (eCRF) specifications (including data capture screens and edit check specifications) needed to build a study-specific clinical database/electronic data capture (EDC) system.
  • Is responsible for the programming and ongoing maintenance of the clinical database.
  • Is responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing).
  • Is responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors.
  • Conducts training for site users/monitors on the clinical database.
  • Develops data transfer agreements and specifications with vendors providing external data (e.g. laboratory results).
  • Conducts reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed).
  • Provides support to study team in the development of external systems capturing clinical data, e.g. ePRO or IWRS, and ensures that any data transfer requirements between these systems and EDC are documented and tested appropriately.
  • Is responsible for the development of the data management plan (DMP), and other clinical data management related documentation.
  • Is responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/close.
  • Codes medical terms in the clinical database, as required.
  • Generates data listings and reports needed for data review by the project manager (or other study team members) in preparation for database close/lock.
  • Monitors study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provides data status reports to the project team, as needed.
  • Ensures that data management documentation is complete and up-to-date in the trial master file (TMF).
  • Activates/de-activates new users in the clinical database in response to requests from the project manager and maintain records of such requests.
  • Responds to users requiring assistance with the EDC system.
  • Is responsible for archiving of the clinical database and related documents.
  • Participates in the definition, writing and updating of data management SOPs.
  • For any studies where any of the above activities have been outsourced to an external service provider:
    • Oversees/manages the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements
    • Ensures that their work is done in accordance with effective work orders and Innovaderm SOPs (if applicable).

 

IDEAL PROFILE

 

Education 

  • B.Sc. or M.Sc. in science, or related field;

 

Experience 

  • Minimum of 5 years of clinical data management experience in the pharmaceutical industry or in a CRO environment
  • 1 year of supervisory experience or project team lead experience, to include data management and/or clinical operations, preferred;

 

Knowledge and skills

  • Must be able to lead multiple studies at the same time;
  • Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines;
  • Extensive experience working with EDC systems, and/or database structures, including demonstrated skills in database programming;
  • Good understanding of CDISC SDTM/CDASH standards; 
  • Highly organized and detail-oriented with effective project planning and time management skills.
  • Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff;
  • Bilingual in English; French is an asset;
  • Demonstrated agility to juggle and prioritize multiple competing demands;
  • Knowledge of MedDRA and WHODrug dictionaries

 

OUR COMPANY

 

 

The work environment

 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities. 

 

As a Manager, Data Management, you will be eligible for the following perks: 

  • Flexible work schedule
  • Permanent full-time position
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
  • Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
  • Ongoing learning and development

 

 

About Innovaderm

 

Innovaderm is a contract research organization (CRO) specialized in dermatology with a team of over 175 employees. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America.

 

We thank you for your application and please note that only those selected for an interview will be contacted.

Innovaderm only accepts applicants with a work permit for Canada.

 

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