The IRT Project Manager is responsible for meeting project timeliness and project deliverables, while managing multiple tasks and clients. Due to the nature of the job, IRT Project managers must present a demonstrated understanding of computer systems and software application implementation (web and/or customer server) including knowledge of software development life cycle. The IRT Project Manager works closely with clients and colleagues to support the clinical study throughout its life cycle. The IRT Project Manager will be responsible for planning project activities, developing the project plan, authoring project documents, reporting on project status, and other supporting project deliverables.
Members of the IRT Services team understand and value the importance of their role in the regulatory approval of new medicines and medical devices. IRT Services Team members support each IRT protocol with knowledge and integrity. Ultimately, the team’s actions serve a vital role in ensuring subjects receive the therapies that could significantly improve their health and wellness and help such therapies to become available for all people.
The Project Manager will be expected to serve as the primary subject matter expert (SME) for the Implementation, Maintenance and Closeout phases of the IRT components of assigned clinical studies. This includes but is not limited to, the following:
- Work as a member of the project team to ensure excellent client relationships are established throughout the study design, development, implementation and maintenance of the study.
- Work closely with clients and colleagues to support the clinical study throughout its life cycle; identifying risk factors, and providing solutions.
- Function as the design expert to advise internal and external customers regarding best practices for IRT design and study configuration.
- Gather and interpret customer requirements and then translate these requirements into design specifications including but not limited to study randomisation schemas and drug supply methodology.
- Design: use cases, test plans, testing summary, training requirements, and quality control documentation to support the development of the IRT design for each specific study.
- Oversee and/or execute Acceptance Testing of the IRT study configuration in the testing environment.
- Coordinate the transition of the IRT study configuration from the testing environment to production environment.
- Validate study implementation in the production environment; match corresponding implementation documents by performing and coordinating quality checks.
- Generate mapping specifications to integrate data to/from other vendors supporting the study.
- Generate data export specifications to support the customer’s data analysis and submission.
- Work with the study team to scope the required effort and define time lines needed to support the multiple phases of the study and as requests are received.
- Actively contribute to the continuing development of the core IRT application and improvements of internal standard working processes.
- Advise customers to ensure that the study trial design is configured to meet the customer’s goals and offer the full benefits of Sharp’s IRT application.
- Fully review and vet all data change requests to ensure the change meets the study design and follows standard working IRT practices.
- Develop all components of a project plan that relate to the proper planning, execution, and close-out of clinical study related efforts.
- Work exclusively with unblinded and confidential clinical study data and information.
- Evaluate IRT study health throughout the life cycle of the study; for example, confirm resupply algorithm processes are functioning as configured.
- Create custom report specifications as requested by the client.
- Provide mentoring and training to junior staff and customer users.
- Prepare for and participate in internal/external audits and regulatory investigations.
Cordant Group is an equal opportunities employer