Job Description

JOB DESCRIPTION: Description: Lead and manage internal IT clinical informatics team and drive, client implementation, improvement and maintenance of clinical systems and technology enabling clinical operations models supported by Transformative Pharmaceutical Solutions, LLC (TPS).Reporting Structure: Head of Clinical OperationsResponsibilities:

• Take responsibility as the technical lead and customer-facing liaison with clients during integration / implementation.
• The expected role level is of Director which means experience level would be 10+ years.
• The selected individual will be expected to travel to United States every 1-2 months.
• Liaise with external vendors and suppliers and project manage (including resource management) software and technology deployment for TPS.
• Hiring, training, mentoring and supervising appropriate internal IT resources as necessary. Accountable for talent and career development of direct reports, including performance management.
• Work with internal stakeholders (Data Sciences, Central Monitoring, QA) to ensure all IT requirements are covered adequately.
• Identify new business enhancements for RAPTOR or other technologies with external clients and lead any agreed development and implementation.
• Work with appropriate stakeholders to identify future enhancements for RAPTOR.

Education & Work Experience Requirements:

• Science or IT degree, or related equivalent certification and/or experience.
• Clinical Trial systems experience that provides the required knowledge, skills and abilities.
• A minimum of 3 years of relevant clinical research IT experience with knowledge of the global drug development process.
• At least 5 years of experience working within the Pharmaceutical industry or with a CRO, preferred.

Required Knowledge, Job-related Skills and Abilities:

• Solid understanding of clinical trial IT systems and data requirements.
• Robust knowledge and experience in international standards (CDISC / CDASH), international (FDA/EMEA) and local regulations.
• Ability to work remotely and to interact with teams within geographical and cultural diversity.
• Knowledge of global drug development process.
• Good computer skills (eCRF, EDC, CTMS), experience with remote monitoring and the ability to learn appropriate software.
• Good leadership, negotiation and project management skills
• Excellent documentation skills. Must be compliant with processes and timelines and have the ability to prioritize multiple tasks in order to successfully meet project timelines.
• Quality focused.
• Fluent in English (oral and written).

Additional Preferred Technical skills:

• Knowledge of AWS - setting up EC2 instance, RDS, S3, Deployment on AWS. Understanding the security setup within the AWS environment
• Basic understanding of PHP and MySQL
• Ability to create and maintain user stories, document requirements, functional specifications, design specifications and traceability matrix for the product
• Competent on JIRA, Confluence, BitBucket usage. (Capability to setup custom issue workflow in JIRA).
• Ability to work in agile mode
• In depth understanding of computer system validation for GAMP5 category 4 and category 5 systems
• Ability to lead the development and validation of multiple client versions in parallel
• Ability to lead validation and maintain the validated state of the product in a regulated environment
• Understanding of CI/CD (Continuous Integration / Continuous Deployment) is a plus

Job Types: Full-time, PermanentSalary: $140,756.31-$150,518.76 per yearBenefits:

• Dental care
• Extended health care
• Vision care

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Mississauga, ON: reliably commute or plan to relocate before starting work (required)