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Duration: 12 Months Contract (extension possible)

About the role:

+ The Senior Clinical Safety Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.

Responsibilities will include:

+ Manage adverse event processing including report review, safety query management, and expedited reporting

+ Assess type/level of processing to be done for adverse events

+ Author study specific safety documents and plans (e.g.: safety plan, CEC/IMR Charter, etc.)

+ Acting member of clinical core team

+ Conduct Clinical Trial Safety Review meetings

+ Ensure adjudication and reconciliation of safety events are completed prior to data snapshots

+ Provide safety-related input to other study documents/processes as requested (e.g.: protocol, CRF design, etc.)

+ Manage functional deliverables to ensure study milestones are not delayed

+ Management of additional projects, deliverables, and timelines to support additional activities within the clinical department

Quality System Responsibilities:

+ In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. For those individuals that supervise others, the following statements are applicable:

Required qualifications:

+ Minimum bachelor’s degree or equivalent experience in science-related field

+ Minimum 5 years clinical trial experience within role of safety required

+ Proven or prior experience with clinical trial safety. Medical device background

Preferred qualifications:

+ Therapeutic knowledge in Urology

+ Knowledge of GCP

+ Experience with processing and assessing safety events and medical narrative writing

+ Clinical database and systems

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com/) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.