Pfizer

Clinical Operations Planning Lead (Sr. Manager)

Employer
Pfizer
Location
Remote, Connecticut
Salary
Competitive
Posted
April 29 2021
Ref
4812082
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
ROLE SUMMARY

An asset or multi-study 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 therapy areas, assets or studies by CRO partners, Pfizer business lines and GSSO global study teams with the goal of:
  • Executing global study start up with industry leading speed while maintaining quality;
  • Provide and support global management teams 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 TA, asset and global study teams (plus CRO partners), for the creation and maintenance of a set of robust planning templates (study/vendor 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 a specific TA or asset class, using services of third party vendors, in-house cross-functional processes;
  • Demonstrate risks and mitigations;
  • Enable work to be predictably forecast and pro-actively allocated across GSSO global roles;


Key collaborator 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 global teams (plus other key stakeholders), this enables monitoring of all aspects of upcoming/current work.

A highly independent worker who can predict, understand and deliver the business needs of global teams managing the execution of clinical trials. Can seamlessly network and influence across the business to achieve challenging goals.

ROLE RESPONSIBILITIES
  • Is a key leader within 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 global teams and their key stakeholders, in the creation/maintenance of a best in class technological back bone for the Pfizer clinical study start-up process.
  • Provides leadership and consultancy to GSSO global teams for clinical study start-up technologies that provide planning and resource management capability
  • Derive creative strategies and tactics to maximize utility of the clinical start-up technology ecosystem within GSSO global teams to achieve aligned multi-functional planning and break through start-up cycle times
  • Leads discrete workstream(s) across key stakeholders groups (Pfizer business, CROs, third party study vendors & software providers) to meet evolving business requirements of start-up systems
  • Drives the provision of an access, training and support infrastructure to clinical study start-up technology users
  • Responsible for oversight of CROs for compliance, status and performance aspects of use of Oracle ACTIVATE and Planisware
  • Is the system SME and may act as owner/administrator functions within the Oracle ACTIVATE and/or Planisware systems and partner with Pfizer Digital to define the mechanisms and controls required to maintain their business integrity
  • In partnership with key business stakeholders define, build, maintain and update planning template libraries in accordance with business priorities
  • Be an exemplar for a continuous improvement culture, taking ownership for systematic recycling of best practice, and intelligence into clinical study start-up technologies
  • Defines, monitors and acts on KPIs measures to actively enforce compliance with key business rules for the use of clinical study start-up technologies
  • Partners across GSSO and partner lines to provide 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 5 years' clinical research working experience at a clinical research site, Contract Research Organisation, software / technology / service provider or sponsor.
  • Minimum of 3 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.
  • Minimum of 1 years as a Subject matter expert 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 with practical application to safe guard quality of clinical studies


PREFERRED QUALIFICATIONS
  • Broad-based experience in clinical research that includes extensive expertise in clinical study start-up
  • Acted as an administrator (or similar role such as designer, back-end configuration) for Oracle ACTIVATE or Planisware or a similar project management / planning / workflow system used to support the start-up of clinical studies
  • Demonstrated technical expertise 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 of leading multiple parties to develop as well as deliver user training and support for clinical study systems or business processes
  • Expert understanding of clinical study start-up activities at study, country and site levels
  • Direct experience in formulating and executing strategies/tactics to accelerate clinical study start up for a specific study(ies).
  • History of success in a customer service support and/or leadership role
  • Excellent verbal and written communication skills among peers, colleagues and management


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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.

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.

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