Sr. Manager/Director, Clinical Data

Job Description:

This position works independently in a team
environment to ensure that clinical studies comply with guidelines
specific to data management. Support data management activities on
assigned protocols in support of project goals. Provide technical
expertise and oversight to staff on all Data Management activities.

Responsibilities:

• Develop protocol standards and ensure standards are applied at the protocol level throughout the course of a study.
• Disseminate pertinent data-related information to appropriate team members.
• Provide an ongoing evaluation of expected/projected accuracy and productivity rates of CDM project tasks (e.g., data entry, review, cleaning, coding, quality control)
• Assist in clinical study report writing and ensure accurate reporting of the study results (e.g., Data Management Plan, data edit specifications, database specification, query management, electronic data transfers, data review, data quality assurance, safety reporting, target monitor plan etc)
• Provide input into the development of SOPs, guidelines, policies, procedures and clinical database functional requirements that enhance data management efficiency and the quality of sponsor deliverables.
• Review and provide feedback on EDC documentation including data entry screens, validation documentation, and edit specifications
• Create and maintain the standard database setup and annotated CRFs for clinical trials to ensure accuracy and integrity of the clinical
• Create/Provide moderately complex ad-hoc reports using SQL or SAS.
• Perform quality control checks of data from listings, spreadsheets, etc. to assess accuracy of data and statistical output
• Determine the best methods to resolve data errors and inconsistencies
• Identify, communicate, and address data issues in a timely fashion
• Research and recommend new data management processes, which address clinical needs and key business objectives;
• Coordinate and execute other assigned project tasks to meet departmental and corporate goals

Requirements:

• BS in Computer Science, Life Science, or other health related field required, advanced degree preferred.
• Minimum 8+ years experience in clinical data management in a pharmaceutical, biotechnology or medical device environment.
• Working knowledge of FDA, GCP, and ICH regulations specific to data management. Appropriate experience and understanding of at least one clinical data management system (e.g. Clintrial, Oracle Clinical, or any EDC system), and a programming language (e.g. SQL, SAS).
• Good understanding of medical terminology.
• Energetic, detail-oriented individual with strong organizational skills and excellent analytical ability.
• Work effectively in team environment.
• Proven written and verbal communication skills.
• Ability to work on multiple projects and prioritize own work.
• Work with minimal supervision in a fast-paced, dynamic environment.
• Must take responsibility for assigned tasks, and must be able to meet critical timelines.

NeuroPace is an equal opportunity employer offering
a competitive compensation and benefits package including medical,
dental, vision, 401(k), and stock options.