Global Clinical Supplies Sr Project Coordinator

Position Summary

As a GCS Senior Project Coordinator, you will provide administrative and technical support to Study Supply Project Team including planning, organizing and coordinating responsibilities of project administration. You will maintain procedures, guidelines and documentation and ensure appropriate maintenance of project records and that all regulatory documents are correct, processed and approved. The Project Coordinator will also complete data entry and maintenance of database repositories, assist in preparation or creation of reports and complete data collection for analysis.

Position Requirements

• Completes review, coordination and compilation of files and other materials.
• Distributes project documents and supplies.
• Processes and tracks local regulatory, study specific or department documents.
• Performs file review. Organizes and maintains correspondence files and other departmental records. Analyzes and reconciles project documents, metrics and findings reports within specified timelines.
• Provides clarification and resolution of findings related to documentation.
• Composes, copies and distributes communications, reports, documents and forms. Performs mass mailings and communications.
• Maintains vendor trackers.
• Provides accesses to company, client and vendor systems.
• Assists on project management ad-hoc activities, producing reports or on study plan edition.
• Coordinates team calls, completes and distributes meeting minutes from internal/client meetings as applicable.
• Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance.
• Maintains a basic knowledge of project protocol and the ability to implement project plans with specific guidelines and accountable for meeting applicable project timelines in accordance with the contract.
• Serves as a resource to the project team.
• Assists in ensuring audit ready files. Contributes to company, client and federal regulatory requirements/audit responses as needed.
• Acts as a mentor for research and project teams by demonstrating the role of an experienced project coordinator in the preparation and execution of all administrative functions.
• Assists in training junior staff and supports departmental leadership in determining training needs.

Education

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).

Knowledge, Skills and Abilities

• Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Strong flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable regulations and procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout
• Solid English language and grammar skills
• Good presentation skills
• Firm computer skills, proficient in MS Office, ability to obtain knowledge and master all database systems and modern technology
• Solid critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Skills to work under constant pressure to meet project/client deliverables and timelines
• Ability to successfully complete required training program(s) as applicable