Responsible for assigned tasks to design, develop, implement, maintain, oversee and continuously improve processes and technologies that empower clinical trial teams to efficiently plan and deliver clinical trials.
Contributes as a member of a capability team, or as a member of a defined project or initiative. They collaborate, build and manage relationships with end users and cross-functional stakeholders, including vendors in matrix environment.
Provide archiving support activities with established procedures and practices including prepare and manage offsite storage, manage chain of custody, assisting with client requests, assisting archivist and other duties as assigned.
Acts as the document coordinator in the Vault Quality Documents (VQD) document management system facilitating activities related to coordinating review of, update and creation of local SOPs, upload of project critical documentation and protocols, reports, and amendments.
Serves as a liaison between the US based GI teams and GI QA on matters related to controlled document management including supporting audit and inspection preparations and providing regular reports.
Qualifications:
Education:
Bachelor’s degree with Project Management and/or Records Management experience required.
Proficiency in Microsoft Office Suite. Excellent communication and interpersonal skills.
Previous experience in pharmaceutical industry and/or familiarity with GLP/GCP/GMP compliance a plus.
Ability to actively and truly engage with customers, building strong customer relationships and delivering customer-centric solutions.
Displays the ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
Ability generate and analyze data to take decisions based on data analysis and interpretation. Ability to effectively build and manage relationships with many different (internal & external) stakeholders.