Associate Project Director – Data Management
The University of Kansas Cancer Center is seeking an Associate Project Director – Data Management. The role of an Associate Project Director is defined as someone who is responsible for maintaining and executing operational aspects of the data management strategy that align with the Cancer Center’s mission.
Position Responsibilities:
· Responsible for the functional management duties for multiple reports, objective setting, performance management, education and training of clinical data coordinators, including the development of Sr. Clinical Data Coordinators.
· Assist with the planning, resourcing and tracking oversight of study data operations department/clinical trial activity from study start-up to close-out. Assess and determine appropriate staffing needs ensuring appropriate workload distribution. Mentor team members to prioritize, solve problems, and plan contingencies.
· Assist with reporting project deliverables such as data entry timelines, data locks, close out visits, audits, etc. by monitoring metrics to senior leadership, study team members and sponsors.
· Participate in the review of proposed trial budgets and assess feasibility and data requirements prior to trial initiation and on an on-going basis; review and approve source documentation and other trial documentation as required.
· Assist in the development and facilitation of standardized process improvements and refinement where necessary to enhance efficiency and quality of work performed on assigned projects.
· Build and maintain strong sponsor and internal team relationships for effective communication in the conduct of clinical trials facilitating effective teamwork.
Position Requirements:
· Bachelor’s degree in life sciences or related field.
· Minimum of 5 years clinical trial experience within the pharmaceutical industry or academia.
· Knowledge of FDA regulations and GCP-ICH guidelines.
· Excellent written and oral communication skills.
· Working knowledge of database software for managing projects and resources.
· Demonstrated ability to work independently and collaboratively.
· Detail oriented and proven ability to multi-task; excellent organizational skills.
· Understanding of Clinical research study start up process.
· Demonstrated ability to manage several project teams and competing priorities simultaneously.
· Prior functional management experience.
· Master’s degree and SOCRA or related certification preferred.