Associate Director Data Management

Overview

Assists the head of Data Management (DM) to manage the department in the development of policies, procedures, and standards in support of project team efforts Develop, recommend, and implement standard procedures, measures of performance, and training programs.

Organize and allocate resources according to multi-project requirements and timelines.

Responsibilities

• Manages a group of statistical analysts, including managers and senior managers.
• May serve as a backup to represent the DM department. Supports the Head of DM to achieve the company’s goals.
• Serves as Lead on the project level to plan, organize, delegate, and manage a team from start to finish by overseeing all development, validation, and production of programs on a project.
• Ensures that resources are well planned and appropriately allocated to all assigned projects based on staff availability, skills, and timelines.
• Ensure that the company business needs, and partner organizations are satisfied within agreed-upon timelines with respect to data management activities and the exchange of data sets for clinical studies.
• Hires and trains highly competent staff that are capable, willing, and motivated to accomplish their responsibilities. Develops staff for current and future positions.
• Recommends all courses of action with regards to management / human resources matters in the department, including salary administration, promotions, transfers, hiring, termination, training and development of managerial and professional staff members, appraisals of performance, employee counseling, and position description preparation.
• Provides review and supervision of the departmental staff in a manner that promotes problem solving, career development, and motivation.
• Develops, revises, and maintains Standard Operating Procedures and Work Instructions.
• Independently brings technical solutions to the Data Management department.
• Understands and complies with Standard Operating Procedures and Work Instructions.
• Stays abreast of current regulatory environment focusing on submission standards.

Qualifications

• Bachelor’s degree or above
• 10+ years of relevant work experience in the pharma / biotech industry, (or otherwise qualified by training or experience).
• 3+ years of managerial experience.

Knowledge / Skills / Abilities :

• Expert knowledge of multiple EDC systems is required.
• Advanced knowledge of the pertinent industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines, is required.
• Demonstrated leadership ability in organizing and motivating staff members.
• Excellent organizational, oral and written communication, and interpersonal skills are essential.
• Solid understanding of statistical programming, statistics and drug development process is required.

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, or protected veteran status and will not be discriminated against on the basis of disability.