ROLE SUMMARY
Reporting to Director of Clinical Research Pharmacy Group with a dotted line reporting to the IRT Global Oversight team (IGOT) Director. The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.
The IGOT Operations Associate role will assist with functions including authorship and/or maintenance of required system documentation, programming queries, and SOP's, as well as system testing and report validation in the support of clinical trials configured within the Pfizer Internal IRT Systems. This role is intended to ensure the patient focused delivery of customer support services in support of Pfizer's evolving portfolio. For this position candidates will need to be a creative problem solver and have a strong commitment to quality to successfully deliver optimal IRT systems across a diverse and dynamic portfolio.
This role will provide support in the development and management of IGOT team SOPs and training documents as well as generating, testing, and validating necessary system SQL reports and performing system documentation reviews required for audit preparedness.
ROLE RESPONSIBILITIES
- Provides application support to customers in an appropriate manner (blinded vs unblinded) using the Pfizer Internal IRT Systems. Customers include IGOT team members, supply chain personnel, and study team members.
- Resolves and document issues reported by customers following the established processes.
- Creates, verifies and validates ad hoc system study reports (e.g. SQL) upon request and provides to study team or supply chain personnel as needed.
- Analyze system updates against SOP's to evaluate for impact to IGOT procedures and assists with the creation of applicable training.
- Ensure the inclusion of appropriate study documents in both the IGOT Support regulatory SharePoint space as well as the Gnosis system
- Review IRT study generated documents for confirmation of completion in preparation for regulatory audits.
- Support IRT system testing, reporting, and monitoring efforts
QUALIFICATIONS
Basic Qualifications:
- Fluent in written and spoken English
- BA/BS, in computer science, scientific, or business field required in biopharma industry.
- Exposure to working in a GMP / GCP environment and with regulatory audit teams
- Comfortable working with a global team, partners and customers in a change agile environment
Preferred Qualifications:
2-3 years of experience with IRT systems preferred
Understanding of the nature of clinical data, with regard to the concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
Database query (SQL), business analysis and technical writing skills a plus
Skilled in working across multiple systems and processes for issue resolution desired
TRAVEL REQUIREMENTS
Travel is limited to approximately 15% for this role
May include international travel for annual department meetings
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Information & Business Tech
#LI-PFE
Pfizer
Reporting to Director of Clinical Research Pharmacy Group with a dotted line reporting to the IRT Global Oversight team (IGOT) Director. The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.
The IGOT Operations Associate role will assist with functions including authorship and/or maintenance of required system documentation, programming queries, and SOP's, as well as system testing and report validation in the support of clinical trials configured within the Pfizer Internal IRT Systems. This role is intended to ensure the patient focused delivery of customer support services in support of Pfizer's evolving portfolio. For this position candidates will need to be a creative problem solver and have a strong commitment to quality to successfully deliver optimal IRT systems across a diverse and dynamic portfolio.
This role will provide support in the development and management of IGOT team SOPs and training documents as well as generating, testing, and validating necessary system SQL reports and performing system documentation reviews required for audit preparedness.
ROLE RESPONSIBILITIES
- Provides application support to customers in an appropriate manner (blinded vs unblinded) using the Pfizer Internal IRT Systems. Customers include IGOT team members, supply chain personnel, and study team members.
- Resolves and document issues reported by customers following the established processes.
- Creates, verifies and validates ad hoc system study reports (e.g. SQL) upon request and provides to study team or supply chain personnel as needed.
- Analyze system updates against SOP's to evaluate for impact to IGOT procedures and assists with the creation of applicable training.
- Ensure the inclusion of appropriate study documents in both the IGOT Support regulatory SharePoint space as well as the Gnosis system
- Review IRT study generated documents for confirmation of completion in preparation for regulatory audits.
- Support IRT system testing, reporting, and monitoring efforts
QUALIFICATIONS
Basic Qualifications:
- Fluent in written and spoken English
- BA/BS, in computer science, scientific, or business field required in biopharma industry.
- Exposure to working in a GMP / GCP environment and with regulatory audit teams
- Comfortable working with a global team, partners and customers in a change agile environment
Preferred Qualifications:
2-3 years of experience with IRT systems preferred
Understanding of the nature of clinical data, with regard to the concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
Database query (SQL), business analysis and technical writing skills a plus
Skilled in working across multiple systems and processes for issue resolution desired
TRAVEL REQUIREMENTS
Travel is limited to approximately 15% for this role
May include international travel for annual department meetings
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Information & Business Tech
#LI-PFE
Pfizer
Other Info
Makati City, Metro Manila
Permanent
Full-time
Permanent
Full-time
Submit profile
Pfizer
About the company
Global Finance Corporate General Accounting Senior General Accountant
ADP
MetroManila, Manila, MakatiAgreement
Position interactive response technology (global oversight team Operations sr associate) with sql recruited by the company Pfizer at MetroManila, Manila, Makati, Joboko automatically collects the salary of , finds more jobs on Interactive Response Technology (Global Oversight Team Operations Sr Associate) with SQL or Pfizer company in the links above
About the company