Senior Study Operations Manager

5 days ago

Apply Now

Receive Emails with Similar Jobs

Pfizer

WebsiteLinkedInAll Job Openings

To apply science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe • effective and affordable medicines and health care services to the people who need them.

10,000+

💰 Post-IPO Debt on 2023-05

Description

• The Country Senior Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close. • The cSOM partners with various roles to ensure a coordinated approach to study start up, execution and close out. • Provides leadership and strategic planning and organization skills to ensure operational delivery of tasks within one or more studies. • Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. • Responsible for management/oversight of regional/country level activities from study startup through conduct and study close. • Supports country/investigator outreach process, site identification and feasibility. • Manages applicable Quality Events with local team as applicable and required. • Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level. • Responsible for country vendor management and oversight including follow up and coordination of vendor deliverables.

Requirements

• BSc/MSc degree is required. • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. • 7+ years of relevant experience. • Extensive operational clinical trial experience. • Demonstrated clinical research experience and/or study management/startup project manager experience. • Demonstrated knowledge of site selection, site activation, site readiness interdependencies. • Demonstrated knowledge of clinical trial methodology and the drug development process. • Demonstrated experience participating on cross functional teams. • Demonstrated experience in Project Management and Quality Management. • Demonstrated experience in a matrix management environment. • Expertise in the use of study/site dashboard and reporting tools. • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility. • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization. • Detail oriented & possesses technical expertise. • Ability to manage complex processes. • Risk Identification & Mitigation. • Strategic Planning, Analytical and Problem-Solving Skills. • Critical Path Analysis. • Ability to adapt to changing technologies and processes. • English is required.