Description
**Responsibilities**
**Project and Timeline Management**
·Manages material management and shipping activities for assigned studies; PK and Immunogenicity testing
·Tracks supplier timelines, deliverables, and study milestones, identifying risks and issues early
·Documents issues, actions, and decisions in accordance with established processes
**Supplier and Stakeholder Coordination**
·Serves as primary point of contact for assigned suppliers
·Communicates updates to suppliers, BAPS, and R&S regarding timelines, issues, and study status
·Coordinates responses to requests for additional testing or information
**Documentation and Reporting**
·Drafts and maintains study documentation, trackers, and reports
·Reviews and submits study reports for internal review
·Supports budget tracking and loss reporting activities
**Compliance and Process Adherence**
·Ensures coordination activities comply with GCP, GLP, and CLIA requirements
·Supports audit readiness through accurate documentation and timely issue resolution
Tools and Systems
·Utilizes SharePoint, spreadsheets, and presentation tools to manage trackers, reports, and communications
Qualifications
_The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent_ _._
Minimum Requirements
•Bachelor’s degree & 2 years of related experience
AND
•Excellent written and verbal communication skills
**Preferred Requirements**
•Experience using electronic document management systems and principles
•Outstanding attention to detail, including the ability to verify data/information, proofread, and reformat documents
•Strong team player working across multiple sites and R&D functions
•Proficient in Microsoft office and online collaboration tools
•Sharp learning agility, problem solving, and multi-tasking skills
•Reliable contributor with the ability to work independently
•Experience in biotechnology or other healthcare environment
**Competencies**
•Understanding and application of principles, concepts, theories and standards of professional field
•Specialized knowledge within the informed consent field, biobank operations, and a basic knowledge about laboratory information management systems
•Drafting and interpreting clinical protocol and ICF language
•Knowledge of related regulatory/industry considerations and compliance issues
