BD (Becton, Dickinson and Company) Post Market Surveillance Clinical Study Specialist in Covington, Georgia
Category: Post Market Surveillance Clinical Scientist/Medical Affairs
Job ID: 2018-11481
Career Level: experienced
Division: Bard Medical Division
Location: Covington,Georgia,United States
BD Urology and Critical Care a BD Company is seeking to fill the position of Post Market Clinical Study Specialist in Covington, GA. This role will serve as project manager within the Medical Affairs division. Bard Medical has joined BD together, advancing the world of health.
Summary of Position with General Responsibilities:
The Post-Market Clinical Study Specialist will lead projects and is responsible and accountable for the management, quality, cost and execution of assigned clinical studies, projects and initiatives. To successfully balance projects across these four areas, the incumbent utilizes risk management tools, strategies and techniques to anticipate and plan for potential risks and manage active issues, employs soft skills including leadership, communication and collaboration to build and lead diverse project teams, and leverages negotiation, analysis and decision-making skills. The role drives value by performing/coordinating activities, information, and tools to produce excellent results aligned with project goals and milestones.
The role may work independently or as part of a larger team in the execution of assigned projects and may assist the Senior Manager, Clinical Sciences in training, mentoring and development programs, organizational planning, and resource allocation.
Essential job Functions:
Coordinates, assists in, or leads the development and execution of study- or project-related deliverables, including but not limited to, project and operational plans, budgets, status reports, and other project-related documents.
Proactive management and conduct of Post Market Clinical Follow-Up projects / studies according to sponsor protocols, including but not limited to, start-up activities, site selection, initiation, interim monitoring and close-out;
Manage and track overall project budget, track and administer payments; provide financial reports as requested.
Ensure compliance with Bard standards, policies and procedures, Good Clinical Practice, and local, regional, and federal regulations.
Leads or assists in the evaluation and selection of project-specific external service providers, including proposal development, competitive bid analysis, defining scope of work and assisting in contract negotiations.
Manages external service providers, ensuring adherence to scope of work, minimizing the management and execution of change orders for assigned projects.
Additional Desirable Qualifications Skills and Knowledge:
Project management certification
Proficient knowledge of regulations related to clinical trials
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status