Clinical Data Specialist

Job Description

Duties and Responsibilities:

• Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.
• Design and implement clinical protocols and data collection systems.
• Develops systems for organizing data to analyze, 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.
• Develops data quality plans.
• Provide early strategic input into protocol design focused on 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.

Differentiating Factors:

Autonomy:

• 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, Product 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.

Education Required:

• Bachelor degree

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.