Clinical Systems Implementation Lead

Responsibilities: 

• Take responsibility as the technical lead and customer-facing liaison with clients during integration / implementation. 
• 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. 

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