Morrisville, North Carolina, United States of America
Full Time
3 weeks ago
Visa Sponsor
Key skills
CommunicationCollaboration
About this role
Role Overview
Creates and maintains the Trial Master File Management (TMF) Plan
Routinely reviews the TMF to ensure quality, completeness and inspection readiness
Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.
Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
Assists with identification of and contracting with approved vendors, as necessary
Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
Assists with development and implementation of change orders
Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones
Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
Attends financial review meetings to assist with reconciliation and identification of budget overrun
Reviews and approves invoices from sites or vendors and to the client
Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively
May participate in Customer proposal development
In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings
Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
Develops knowledge of current therapeutic environment
Requirements
Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred
Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
Strong organizational skills
Strong ability to manage time and work independently
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
High level of competency in English language
Proficiency with MS Office Applications
Ability to travel as necessary (up to 25%)
Benefits
company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance