Clinical Data Spec

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A Day in the LifeBusiness title will be Clinical Safety Specialist.
Responsibilities may include the following and other duties may be assigned.
Collaborates with various stakeholders on the design, documentation, testing and implementation of clinical data collection studies, and clinical data review.
Design and implement clinical protocols and data collection systems.
Develops systems for organizing data to analyze, code, identify and report data and trends.
Manages data management issues by reviewing protocols for cross-project consistency and identifying standard Case Report Form (CRF) modules to meet objectives.
Provide early strategic input on protocol design focused on safety and/or data management issues.
Review and resolve data discrepancies for standardized data validation systems and procedures.
Prepares reports of clinical trial studies for internal validation and cross validation studies.
Reports out in compliance with Regulatory reporting requirements.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation
- while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORSAutonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and

Experience:
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.
F.
R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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