Planning and Activation Lead (Sr. Manager)
Acts as an enterprise-level business lead for the Activate and Analyze systems used within the Pfizer clinical study start-up process to define and manage site activation workflow.
Effectively engages with CRO partners, Pfizer business lines and study teams 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
- Defines governance framework and key performance indicators to support oversight of CRO partner organizations ensuring complete, timely and consistent Activate data.
- Partners with internal functional lines & vendor on Activate system and process integration activities
- Develops and maintains Activate and Analyze training materials, 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, training and support to internal and external system users and study team stakeholders.
- Ensure consistent utilization of Activate and Analyze for startup planning and reporting activities
- Contributes to the establishment and delivery of start up analytics and metrics against an agreed upon set of KPIs/goals
- Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies supporting Global Site and Study Operations startup analytics and planning
- Engages with vendors where applicable to evolve innovative capabilities in startup planning and reporting
- Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity
- Extensive working experience in goBalto/Oracle Activate or a similar workflow solution.
- Understanding of goBalto/Oracle Analyze or similar workflow reporting module to provide real-time visibility into study startup processes utilizing analytics and dashboards.
- Familiarity with Activate Configuration Designer functionality or configuration functionality in a similar workflow solution would be an asset.
- Experience in accelerating clinical study start up. 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.
- A broad based experience in clinical research is preferred. Knowledge of GCP and a good understanding of the processes associated with study start up, feasibility and enrollment planning.
- Knowledge of drug development and a thorough understanding of the processes associated with feasibility, clinical study start-up and business operations
- 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
- In general, candidates for this job would have 5 to 8 years of experience in Clinical research
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
The closing deadline for applications is January 26th.
All applicants must have the relevant authorisation to live and work in the EU.