Job Purpose: The primary role of the Process Delivery Specialist is to provide tactical management and leadership to core teams in order to ensure that project related tasks are completed in a timely fashion, so that project deliverables can be met. The position provides the Project Manager with timely project status information and serves as the key operational interface between Medical Imaging Operations and Project Management.

Key Accountabilities:

Project Management

- Use recommended portfolio, program, departmental, and project processes and workflows for planning, scheduling, and tracking.

- Monitor study progress and alert Project Manager and other involved study team members of any resourcing or timeline issues (e.g., review study status reports and perform recurring checks on data in the Calyx database).

- Perform a recurring quality check on project files.

- Support the Project Manager during internal and external study team meetings, as needed, taking meeting minutes if required.

- Assist the Project Manager with study document and slide creation as needed.

- Act as a Project Manager's back-up during out of office times and act as the point of contact for clients during that time.

- Assist on image processing and site support questions / requests.

- Create Data Change Requests and check that they were properly executed. Methods & Tools

- Provides advice / guidance / expertise to support adoption of methods and tools and adherence to policies and standards, process tailoring in line with agreed standards and evaluation of methods and tools.

- Reviews and improves usage and application of methods and tools

Specialist Advice

- Actively maintains knowledge in one or more identifiable specialisms and provides detailed and specific professional advice regarding the application of their specialism(s) to the organisation's operations.

- Recognises and identifies the boundaries of their own specialist knowledge, seeking to work with other specialists where appropriate, to ensure advice given is appropriate the needs of the organisation.

Project Monitoring & Reporting

- Regularly review the status of site qualification, image processing, result reporting, and query management across all supported projects, and follow up with the appliable internal groups as needed.

- Send independent review results for applicable projects.

- Monitor the status of the independent reviews and communicate status to the independent reviewers / Project Manager as necessary.

- Compile and distribute study report as needed. Verify the correctness of the reports and ensure they are distributed to the internal and external study team members as appropriate or filed in a collaboration area on a study specific portal.

- Identify any needs for additional or non-standard reporting and work with Project Manager or other study team members on the requirements. Requirements Definition Management

- Defines and manages scoping, requirements definition and prioritisation activities for small scale changes and assists with more complex change initiatives. - Follows agreed standards to elicit and document detailed requirements using the most appropriate techniques.

- Reviews requirements for errors and omissions.

- Inputs to the requirements base-line. Investigates and processes and applies requests for changes to base-lined requirements.

Data Management

- Assist Project Manager in setting up data reconciliation as needed.

- Assist Project Manager in following up with the Data Management team or SciMed for creation/review of data quality monitoring outlier report as needed. Reviewer and Case Assignment Management

- Send independent reviewer communications as needed.

- Support and/or perform case assignment for independent review act as liaison with 3rd party providers and/or consultants.

Relationship Management

- Implements stakeholder engagement/communications plan.

- Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information.

- Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management.

- Helps develop and enhance customer and stakeholder relationships.

Other

- Support any other reasonable duties as requested by the Project Manage

Skills:

- Excellent interpersonal, verbal, and written communication skills

- Detail oriented and highly organized

- A flexible attitude with respect to work assignments and new learning

- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

- Must have the ability to work methodically in a fast-paced, time-sensitive environment

- Demonstratable ability to apply critical thinking to problems and tasks - Builds and maintains an in-depth knowledge of imaging & modalities within the life sciences industry and how they affect customers adopting our products

- Ability to identify and implement process improvements

- Proactively participates in skills improvement training

- Maintains an up-to-date awareness of trends, tools, technology, techniques, and processes of the department

- A self-starter and able to work under own initiative

- Proven ability of using Microsoft 365 products (including Word, Excel & PowerPoint)

Knowledge and Experience:

- Demonstrable experience in clinical trials or in a relevant project management support role

- Experience using tools to effectively communicate progress to internal and external stakeholders

- Experience working within regulated environments

- Experience of working in and knowledge of the life sciences sector

- Medical Imaging experience in clinical setting preferred

Education:

- Bachelor's Degree in a biological science, health science technology or equivalent education with relevant work experience

- English: Fluent

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We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.