Specialist, Clinical Data Management

About the role

Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.

Responsibilities

• Selects optimal experimental designs, defines endpoints, and identifies and/or develops appropriate statistical methods of analysis for protocols developed in-house as well as by Contract Research Organizations (CROs)
• Participates in the development and review of clinical trial data capture processes and media, including electronic data capture methods and paper case reports forms (CRFs)
• Ensures that all protocol-required data are collected in consistent formats that reflect any applicable standards
• Reviews and approves data management plans and database quality control/audit plans prepared by CROs
• Ensures that appropriate data edit check specifications, quality control checks, and audit procedures are implemented
• Prepares and approves statistical analysis plans, and collaborates with CRO biostatisticians in the preparation of statistical analysis plans as necessary
• Oversees and monitors CRO performance of biostatistics and data management tasks to ensure that timelines are met and that any resource issues are identified and resolved
• Provides biostatistical support to non-clinical areas of the company, including consulting and data analysis
• Selects and implements statistical software

Requirements

• BS/BA degree and 2+ years of relevant experience, OR Master’s degree and some related experience, OR JD or PharmD or PhD and some related experience
• Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers
• Experience in specific functional discipline while working to acquire higher-level knowledge and skills
• Comfortable with tools and processes that support work conducted by functional area
• Ability to work as part of a team
• Strong computer skills
• Good communications, problem-solving, analytical thinking skills
• Detail oriented
• Able to meet deadlines
• Good project management skills
• Thorough understanding of data management processes is essential
• Strong SAS skills required
• Excellent oral and written communication skills are required

Qualifications

• BS/BA degree and 2+ years of relevant experience, OR Master’s degree and some related experience, OR JD or PharmD or PhD and some related experience

Skills

• Understanding of Neurocrine's business objectives and developing understanding of Neurocrine's services and customers
• Experience in specific functional discipline while working to acquire higher-level knowledge and skills
• Comfortable with tools and processes that support work conducted by functional area
• Ability to work as part of a team
• Strong computer skills
• Good communications, problem-solving, analytical thinking skills
• Detail oriented
• Thorough understanding of data management processes is essential
• Strong SAS skills required
• Excellent oral and written communication skills are required

Benefits

The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.