Associate Director, Site Activation Partner Team Lead

ROLE SUMMARY

The Site Activation Partner Team Lead is responsible for overseeing and supporting operational activities managed by Site Activation Partners (SAP), on internalized sites and studies in start-up, activation, initiation, through maintenance and close-out to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

SAP Team Lead supports the SAP Group Lead, and the SAP team on tasks assigned related to the development of processes, Local country knowledge and process improvement to optimize sites activation.

The SAP Team Lead is also responsible for managing a group of SAPs (10-15 or more) who may be located in various countries, and who are providing operational support to global clinical trials.

ROLE RESPONSIBILITIES

• Support the SAP Group Lead in the collaboration across GSSO roles and stakeholders to contribute to internalized sites and studies Strategy and implementation
• Supervises closely the implementation of the activities by SAPs on studies and investigators sites to ensure High Quality, Timely and Cost-Effective Site Initiation and ongoing maintenance of critical documents
• Support the build and maintenance of Country and Site Initiation (Ethics/IIP) Regulation and Requirements, and intelligence network informed by local knowledge and expertise
• Deep understanding of the Investigator Initiation Package (IIP) components, requirements, Quality package and processes
• Liaise and collaborate with the Pfizer IIP group Team Lead on processes, SOP changes and SAP performance and quality
• Maintain ongoing contact and communication with stakeholders in country and study team to ensure alignment with SAP role understanding and implementation
• As needed collaborate with global/local stakeholders in preparation for and providing responses to site audits / inspections
• Build relationships and Connect with Process Leads to ensure alignment with SAP role, SOPs and processes

Manager Responsibilities:

• Direct line management of a number of Site Activation Partners (minimum of 10-15)
• Responsible for the talent development of colleagues
• Management oversight of Team performance and work behaviors to ensure work effectiveness and efficiency
• Oversee and coach SAPs to ensure they have the technical knowledge and experience to work with cross functional stakeholders
• Contribute to the overall strategy and evolution of the team
• Lead process improvement projects
• Participate as SME in global initiatives representing the functional line

BASIC QUALIFICATIONS

• Bachelor's degree or above
• Minimum of 8-10 years' experience in Clinical Trials environment
• Excellent oral and written English skills. Additional language is an asset.
• Excellent interpersonal skills
• People management including recruitment, coaching, and performance management
• Flexible in handling resources and be able to quickly address short- and long-term resourcing needs

PREFERRED QUALIFICATIONS

• Ability to work well and lead direct reports in a virtual environment and in matrix and multi-cultural organization
• Demonstrated knowledge of clinical research and development key operational elements and processes and ability to gain command of process details
• Demonstrated knowledge of ICH/GCP, FDA, global and local regulatory and Ethics requirements

• Ability to work under pressure and tight timelines
• Required to support multi-national team members, and flexibility in working hours may be needed occasionally
• Travel required for business meetings when applicable

Other Job Details

• Eligible for Relocation Package - NO
• Additional Posting Locations - Canada - Quebec - Kirkland; United States - Remote; Canada - Remote

Eligible for Employee Referral Bonus: YES

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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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