Clinical Operations Planner - Chennai, India - Pfizer

Pfizer

Verified Company

Chennai, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

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 incountry 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 realtime of working in countries/regions.
Demonstrate risks and mitigations.
Enable work to be predictably forecast and proactively 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 startup technologies
Responsible for representing the business needs of GSSO incountry teams and stakeholders, in the creation/maintenance of a best in class technological back bone for the Pfizer clinical study startup process
Consultant to GSSO incountry teams for clinical study startup technologies that provide planning and resource management capability
Derive maximal utility of the clinical startup technology ecosystem by incountry teams to achieve aligned multifunctional planning and break through startup cycle times
Partners with assigned stakeholders (Pfizer business, CROs, third party study vendors & software providers) to meet evolving business requirements of startup systems
Key contributor in the provision of an access, training and support infrastructure for clinical study startup 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 startup technologies for assigned regions and countries
Supports the build and provision of a creative business analytics reporting environment covering startup 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 startup of clinical studies.
Excellent knowledge of ICH-GCP and how it applies to the quality of clinical studies

PREFERRED QUALIFICATIONS

Broadbased experience in clinical research that includes expertise in clinical study startup
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