Clinical Operations Planner

Parexel International Corporation

Canada, Remote

The Clinical Operations Planner is a multi-talented individual who has a keen business understanding of site and country study start up that marries with excellent technical acumen of project management and workflow tools. The Clinical Operations Planner has the ability to provide the knowledge and communicative bridge between digital and IT teams and in country client teams to deliver innovative solutions to evolving business needs. The Clinical Operations Planner is a regional or country level business lead for one or many of the key systems (namely Planisware and Oracle ACTIVATE) used by the client primarily during the start up period of client clinical trials.

Operations

Member of the Operations Planning team that provides client business support for Planisware and/or Oracle ACTIVATE used as client clinical study start up technologies
Responsible for representing the business needs of client in country teams and stakeholders, in the creation and maintenance of a best in class technological back bone for the client clinical study start up process
Consultant to client in country teams for clinical study start up technologies that provide planning and resource management capability
Derives maximal utility of the clinical start up technology ecosystem by in country teams to achieve aligned multifunctional planning and break through start up cycle times
Partners with assigned stakeholders (client business, Contract Research Organizations (CROs), third party study vendors and software providers) to meet evolving business requirements of start up systems
Key contributor in the provision of an access, training and support infrastructure for clinical study start up technology users with a focus on those that are regionally or country aligned
Provides oversight of assigned CROs for compliance, status and performance aspects of use of Oracle ACTIVATE and Planisware
Builds, maintains, and updates designated planning template libraries within Planisware in partnership with assigned business stakeholders
Is a key part of a continuous improvement culture ensuring consultancy services provided on clinical study startup technologies represents current best practice, intelligence and process standards
Monitors and acts on Key Performance Indicators (KPI) measures to actively enforce compliance with key business rules for the use of clinical study start up technologies for assigned regions and countries
Supports the build and provision of a creative business analytics reporting environment covering start up compliance, status and performance as well as associated KPIs
Derives as well as executes the strategy and tactics required for the consistent use of key systems in support of specific regions or countries by CRO partners, client business lines and in country teams with the goal of:
- Executing country start up with industry leading speed while maintaining quality
- Provides and support in country managers with the use of a resource management capability to predictably forecast and efficiently manage work allocation as well as prioritization
Provides business as well as technical expertise to regional and country aligned teams (plus CRO partners), for the creation and maintenance of a set of robust planning templates (country and/or site level) that are:
- Accurate predictors for delivery of key start up tasks and milestones;
  - Reflect current best practice;
    - SOP aligned
    - Incorporate institutional knowledge in near real-time of working in countries and/or regions
    - Demonstrate risks and mitigations
    - Enable work to be predictably forecast and pro-actively allocated within a country and/or region

Collaboration

Works with in house digital as well as external software vendor teams to provide a best in class business analytics platform and support structure for regional or country aligned teams (plus other key stakeholders), enabling the monitoring of all aspects of upcoming and current work

Interacts with as a regular part of the job responsibilities the following roles, including any external interactions as appropriate:
- Study Start Up Project Managers
- Directors of Study Start Up Project Management
- Study Managers
- Directors of Study Management
- Site Relationship Partners
- Directors of Clinical and Site Operations
- Site Activation Partners
- Site Activation Partner Leads
- Feasibility Leads
- Client Digital
- Business Process Owner and Key Domain Owners
- Contract Research Organization personnel
- Software vendors (Oracle ACTIVATE, Planisware)

Subject Matter Expert (SME)

SME for Oracle ACTIVATE or Planisware or a similar project management / planning / workflow system used to support clinical studies
Acts as SME and administrator within the Oracle ACTIVATE and/or Planisware systems and in conjunction with client Digital maintain their business integrity

Compliance with Parexel standards

Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

Demonstrated technical acumen in the creation and use of business analytics, KPIs, and dashboards to monitor, assess, as well as inform the planning and execution of clinical studies
Excellent verbal and written communication skills among peers and colleagues
Fluency in written and spoken English required

Knowledge and Experience:

Excellent knowledge of ICH-GCP and how it applies to the quality of clinical studies required
Broad based experience in clinical research that includes expertise in clinical study start up, preferred
Experience with development as well as delivery of user training and support for clinical study systems or business processes, preferred
Solid understanding of the activities involved in site selection, IRB/IEC submissions and approvals, clinical trial applications to competent authorities, site essential document processing, contract and budget negotiations, and site enrolment readiness
Understanding of the key factors that influence the ability to accelerate clinical study start up especially focused on site and country level activities
History of success in a customer service support role preferred
Minimum of 3 years’ clinical research working experience at a clinical research site, CRO, software / technology / service provider or sponsor required
Minimum of 2 years’ moderate working experience in either Plansiware or Oracle Activate or a similar project management / planning / workflow system used to support the start up of clinical studies required

Education: