Kim Squires Email and Phone Number

Coordinate implementation of service operational initiatives; system requirements; client requests & electronic reporting. Demonstrate thorough understanding of project protocol, therapeutic indication, budget & scope of work. Provide historical perspective & input on operational processes in collaboration with project leads. Provide leadership to team & mentoring/coaching to junior staff. Promote sharing of ideas within team to improve process efficiencies. Ensure team is following standard best-in-class practices. Establish communications with management to ensure the team is providing high quality deliverables & meeting client expectations & to discuss general project status, milestones, scope of work, project issues etc. Work with project management to achieve project deliverables; proactively identifying issues & proposing solutions & delegating client requests & implementation of new initiatives. Establish & maintain effective service operations communications & provide regular feedback to operations manager; clinical project manager on project challenges/issues/successes. Maintain positive, collaborative team environment with project team members, encourage, motivate & lead by example, provide training & mentoring for project team members & operations staff, oversee allocation of team & project resource. Communicate confidently to logistics & practicality of new processes. Collaborate with operational team & managers to resolve issues relating to employee performance, efficiency & morale. Ensure staff are trained on & are following SOPs, Good Clinical Practice, FDA/ICH guidelines /regulations, Working Instructions & project instructions. Implement & support service operational decisions by senior management. Participate in training. Contribute & assist in global/local working groups in implementation of new operational initiatives, identification & implementation of process efficiencies. Lead team to achieving departmental goals.

Receive, triage, review and process Lifecycle safety operational data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission.

Review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOP’s and internal guidelines. May provide oversight on projects with limited complexities for activities on small to medium service operational projects.

Review, assess and process Lifecycle Safety data and information, across all service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Technical activities including inputting prescriptions, counseling patients on medication utilization, suggesting non-prescription therapeutic agents, filing insurance information, compounding various dosage forms, transferring prescriptions, inventory assessment and ordering, interacting with various health care professionals concerning patient medication history.

Technical activities included interacting with customers, inventory, answering phone calls

Technical activities included interacting with customers, inventory, answering phone calls