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53907879 Operations Planner (Manager) - Madison, NJ

Job Information

ID :
#35910605
# of Positions :
1
Minimum Education Level :
Unspecified
Experience Required :
3+ years
Duration :
Full Time Regular
Shift :
Unspecified
Hours per week:
40

Job Description

 

ROLE SUMMARY
A regional or country level business lead for one/many of the key
systems (namely Planisware & Oracle ACTIVATE) used by Global Study and
Site Operations (GSSO) primarily during the start-up period of Pfizer
clinical trials (start-up)

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 prioritisation

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 Oracle ACTIVATE 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 multi-functional 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 Oracle ACTIVATE and Planisware
Acts as SME and administrator within the Oracle ACTIVATE 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 start-up 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 Organisation, software / technology /
service provider or sponsor.
Minimum of 2 year 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.
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
Experience with development as well as delivery of user training and
support for clinical study systems or business processes
Solid understanding of the activities involved in site selection,
IRB/IEC submissions/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
Excellent verbal and written communication skills among peers and
colleagues

\#LI-PFE
\#LI-Remote

Sunshine Act
Pfizer reports payments and other transfers of value to health care
providers as required by federal and state transparency laws and
implementing regulations. These laws and regulations require Pfizer to
provide government agencies with information such as a health care
provider's name, address and the type of payments or other value
received, generally for public disclosure. Subject to further legal
review and statutory or regulatory clarification, which Pfizer intends
to pursue, reimbursement of recruiting expenses for licensed physicians
may constitute a reportable transfer of value under the federal
transparency law commonly known as the Sunshine Act. Therefore, if you
are a licensed physician who incurs recruiting expenses as a result of
interviewing with Pfizer that we pay or reimburse, your name, address
and the amount of payments made currently will be reported to the
government. If you have questions regarding this matter, please do not
hesitate to contact your Talent Acquisition representative.

Medical

EEO & Employment Eligibility:

Pfizer is committed to equal opportunity in the terms and conditions of
employment for all employees and job applicants without regard to race,
color, religion, sex, sexual orientation, age, gender identity or gender
expression, national origin, disability or veteran status. Pfizer also
complies with all applicable national, state and local laws governing
nondiscrimination in employment as well as work authorization and
employment eligibility verification requirements of the Immigration and
Nationality Act and IRCA. Pfizer is an E-Verify employer.

Company Information

Name :
Description :
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

We have a leading portfolio of products and medicines that support wellness and prevention, as well as treatment and cures for diseases across a broad range of therapeutic areas; and we have an industry-leading pipeline of promising new products that have the potential to challenge some of the most feared diseases of our time, like Alzheimer's disease and cancer.

To ensure we can continue to deliver on our commitments to the patients, customers and shareholders who rely on us, we are focused on improving the way we do business; on operating with transparency in everything we do; and on listening to the views of all of the people involved in health care decisions. Through working in partnership with everyone from patients to health care providers and managed care organizations to world governments and non-governmental organizations, our goal is to ensure that people everywhere have access to innovative treatments and quality health care.


Type :
Direct Employer
Address :
235 East 42nd Street
New York, NY 10017

Application Information

Online :
Job Posting Entered On :
4/26/2021
Job Posting Expires On :
7/25/2021