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ROLE SUMMARY
A regional or country level business lead for one/many of the key systems (namely Planisware & SalesForce)
used by Global Study and Site Operations (GSSO) during the lifecycle of Pfizer clinical trials.
Derives as well as executes the strategy/tactics required for the consistent use of key systems in support of specific
regions or countries by CRO partners, Pfizer business lines and GSSO in-country teams with the goal of:
- Executing country start up with industry leading speed while maintaining quality
- Provide 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 GSSO regional and country aligned teams (plus CRO partners), for
the creation and maintenance of a set of robust planning templates (country/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/regions.
- Demonstrate risks and mitigations.
- Enable work to be predictably forecast and pro-actively allocated within a country/region.
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 GSSO regional or country aligned teams (plus other key stakeholders), this enables
monitoring of all aspects of upcoming/current work.
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. Has the ability to provide the
knowledge and communicative bridge between digital/IT teams and in-country GSSO teams to deliver innovative
solutions to evolving business needs.
ROLE RESPONSIBILITIES
- Is a member of the Operations Planning team that provides GSSO business support for Planisware and/or SalesForce used as Pfizer clinical study start-up technologies
- Responsible for representing the business needs of GSSO in-country teams and stakeholders, in the creation/maintenance of a best in class technological back bone for the Pfizer clinical study start-up process
- Consultant to GSSO in-country teams for clinical study start-up technologies that provide planning and resource management capability
- Derive 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 (Pfizer business, CROs, third party study vendors & 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 Planisware and/or SalesForce
- Acts as SME and administrator within the SalesForce and/or Planisware systems and in conjunction with Pfizer Digital maintain their business integrity
- In partnership with assigned business stakeholders build, maintain and update designated planning template libraries within Planisware
- Be 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 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
BASIC QUALIFICATIONS
Degree qualification (BSc/BS and/or MSc/MS/MBA) with all of the following:
- Minimum of 3 years’ clinical research working experience at a clinical research site, Contract Research Organization, software / technology / service provider or sponsor.
- Minimum of 2 years moderate working experience in either Plansiware or Oracle (goBalto) or a similar project management / planning / workflow system used to support the start-up of clinical studies.
- Excellent knowledge of ICH-GCP and how it applies to the quality of clinical studies
PREFERRED QUALIFICATIONS
- Broad-based experience in clinical research that includes expertise in clinical study start-up
- Subject matter expert for Oracle ACTIVATE or Planisware or a similar project management / planning / workflow system used to support clinical studies
- Demonstrated technical acumen in the creation/use of business analytics, Key Performance Indicators (KPIs) and dashboards to monitor, assess as well as inform the planning / execution of clinical studies
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