SUMMARY DESCRIPTION

The DMS Operations Associate Director role is responsible for all for all study-related data management activities, including protocol review, eCRF development, Data Management Plan development, Data Validation Plan development, reconciliations, and the delivery of complete, correct, and consistently fit-for-purpose study data sets for statistical analysis.
The Associate Director may also act as Process Improvement / Departmental Initiative Lead, as needed.

COMPETENCIES

Decision Making, Critical thinking and Problem Solving, such as skill in the ability to gather data and input, using multiple sources if applicable, to develop holistic understanding of problems and propose comprehensive solutions.
Influence, Cross-Functional Collaboration and Organizational Awareness, by seeking opportunities to interact with peers and stakeholders; builds a network of internal and external peers.
Agility and Proactivity, by being able to demonstrate resourcefulness to find, and resolve to be comprehensive in obtaining, information needed for complete and timely close out of tasks and deliverables.
Leadership, such as skill in clearly communicating objectives, goals, and expectations to others. Emerging understanding of study team roles and responsibilities and how they contribute to overall priorities; recognizes opportunities to improve study deliverables to support the organization.
Communication, including an ability respond promptly to stakeholders, peers, and management with clear and organized messages and ensures that important information is shared in a timely manner.
Strategic Thinking and Planning, such as an ability to focus on performance measurement to track progress toward objectives.
Operations, such as being able to demonstrate basic understanding of how programming supports study execution phases; ask questions and seeks guidance to clarify understanding and priorities. Experienced with clinical data programming and able to review and evaluate clinical data. Communicates design/specs in an unambiguous manner and adjusts communication as per the context.
General data management science skills, such as the development of comprehensive data validation plans in accordance with standards/SOPs; consistently approaches data validation and data quality planning with a focus on process improvement. Understands the objectives/purpose of each drug development phase (I-IV) and the related key cross-functional deliverables. Demonstrates basic knowledge of relevant products(s), the disease/condition that the product(s) treat, mechanism of action, efficacy, safety profile, and development status. Familiar with key medical coding terms and reporting formats; able to review and identify potential issues based on coding.

EDUCATION AND EXPERIENCE

• PhD or MA degree preferred; or BA/BS degree with a focus in data science, statistics, computer science, life science, or related scientific discipline
• 3+ years of experience in clinical development, including technical experience within and outside of Data Management Science, with PhD; or 5+ years with MS; or 8+ years with BS

DMS Operations Associate Director may perform a range of the following responsibilities, depending upon the studies’ complexity and studies’ development stage: