Planning and Activation Lead (Manager)
Acts as a business lead for the Activate and Analyze systems used within the Pfizer clinical study start-up process to define and manage site activation workflow.
Primarily engages with study teams, as well as CRO partners and Pfizer business lines to enable timely and consistent utilization of Activate/Analyze to support the planning and execution of study start up and selected activities in study maintenance.
Will work with study teams to effectively predict delivery to study start up plans and mitigate risks through the implementation and use of Activate and Analyze.
Supports initiatives to leverage Activate data to inform more consistent and accurate study start up timeline projections that drive study team decision making and enhance predictable delivery of the portfolio.
Acts as an Activate and Analyze subject matter expert for internal and CRO enterprise partners
- As the representative of the business owner of Activate / Analyze own the relationship with at least one CRO partner or internal business line
- Provides proactive oversight of the Activate user community (Split across CRO partner organizations and internal Pfizer users) to establish processes that assure the overall quality and timeliness of all Activate data.
- Supports the development of key performance indicators to define the quality of Activate data.
- Partners with internal functional lines & vendor (Oracle) on Activate system and process integration activities
- Develops, maintains and delivers Activate and Analyze training, supporting documentation and other user materials as well as associated communications
- Contributes to periodic system configuration updates and version upgrades through ongoing assessment of regulatory, country-specific, business process and end user requirements
- Provide Activate Subject Matter Expertise supporting internal and external system users and study team stakeholders.
- Ensure consistent utilization by study teams (individuals from CRO partners and Pfizer) of Activate and Analyze for startup planning and reporting activities that match Pfizer current business process
- Contributes to the establishment and delivery of start up analytics and metrics against an agreed upon set of KPIs/goals
- Supports a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity
- Working experience in goBalto/Oracle Activate or a similar workflow solution.
- Acute understanding of goBalto/Oracle Analyze or similar workflow reporting module to provide real-time visibility into study startup processes utilizing analytics and dashboards.
- Experience within clinical research at clinical site, CRO or sponsor. A broad-based experience in clinical research is preferred.
- Demonstrated technical acumen using and developing systems/tools for status reporting and data analytics
- Experience with working with business lines / IT groups / vendors to develop or roll-out new systems and/or new functionality
- Solid understanding of the workflows involved in site selection, IRB/IEC submissions/approvals, site essential document processing, contract and budget negotiations, and site enrollment readiness.
- Understanding of the key factors that influence the ability to accelerate clinical study start up.
- Knowledge of drug development, GCP and a good understanding of the processes associated with study start up, feasibility and enrollment planning.
- History of success in a customer service role with a demonstration of meeting customer expectations.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
Position holder will work remotely from a home based office (remote working position), proximity to a Pfizer site is NOT a requirement, expectation is to work with Europe/Americas time zones predominantly.
All applicants must have the relevant authorisation to live and work in the EU.
The closing deadline for applications is January 26th.