he Clinical Project Specialist supports Clinical Project Management in the areas of product development and commercialization through the execution of Clinical Trials. The Clinical Project Specialist has knowledge of Clinical Project Processes and can execute trial related activities with or without guidance as necessary. The Clinical Project Specialist is familiar with internal Clinical SOPs, has knowledge of GCPs and understands the Clinical Study Protocol.
•Contributes to protocol, ICF, IB and Reg submission creation.
•Executes CDAs and supports creation of CSAs and site budgets.
•Attends Clinical Project Meetings and manages Meeting Minutes.
•Executes study payments, manages device tracking/accountability and responsible for site management activities.
•Uses internal systems to update project milestones and study timelines.
•Manages Master study file.
•Creates site Regulatory binders and other site materials.
【Job Scope and Leveling Guidelines】
A seasoned, experienced professional with wide-ranging experience and expertise in a specialized field. Applies comprehensive knowledge of a particular field to resolve complex issues in creative ways. Full knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Is recognized as an expert in the work group.
Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions.
◆Planning and Organization
Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones.
◆Discretion/Latitude; Supervision Received; Decision Making
Works without appreciable direction. Works independently on highly specialized projects with long range objectives. Exercises considerable latitude in determining objectives of assignment. Selects methods and techniques to lead a project to completion. Develops departmental policies and procedures, new techniques and standards. Work is reviewed from a relatively long- term perspective, for desired results.
◆Business Relationships and Project Management
Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized project teams which have a broad impact on the company utilizing cross-functional resources. Provides leadership to business units.
Guides the successful completion of major programs and often functions in a project leadership role. Effects of decisions are long-lasting and influence the future course of the organization. Errors in judgement or failure to achieve results would result in the expenditure of large amounts of company resources.
Serves as a consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, projects, or objectives. Uses diplomacy and tact to diffuse high tension situations, particularly with senior level internal and external contacts. Occasionally escalates the most serious issues to manager.
Participates in the development of others by facilitating training and providing feedback and guidance.