UNC’s Clinical Protocol Office has recently posted two Clinical Trial Activation Project Manager positions.
The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is a 50 National Cancer Institute (NCI)-designated comprehensive cancer center. The Center’s mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.
UNC Lineberger’s Clinical Protocol Office is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.
The UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The UNC Lineberger Oncology Clinical Protocol Office (CPO) is primarily responsible for organizing, managing, conducting, and supporting these trials. This position will project manage activation of treatment clinical trials run by the CPO. This includes project planning and execution, during which this position will schedule activities and project completion dates. This position will lead, coach, motivate and influence assigned study team members to ensure timely completion of high-quality deliverables and staff accountability for assigned tasks. The position will monitor the progress of activation of assigned trials using PERT charts to determine allowed slack times, critical path deliverables and key milestone deadlines. The individual will monitor team performance against expectations to proactively identify problems and to determine their potential impacts. The individual will then propose potential corrective actions in order to overcome any hurdles to trial activation.This individual will provide comprehensive and transparent updates to stakeholders as to activation progress. Additionally, the individual will be responsible for tracking trends and analyzing data in regards to pitfalls to activation and proposing initiatives to address hurdles.This individual will also be responsible for training staff and investigators on project management basics.
Minimum Education and Experience Requirements:
Bachelor’s degree with at least 5 years of clinical trial or project management experience.
Qualifications and Experience:
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) guidelines.
Understanding of project management principles including PERT and Gantt Charts. Project Management Professional (PMP) certification desirable, but not required. Previous experience in clinical trial activation required; experience in clinical trial activation for oncology trials preferred.
Possess excellent interpersonal skills including leadership, team building, motivation, communication, influencing, decision making, political/cultural awareness, negotiation, trust building, conflict management and coaching. Possess a broad understanding of psychology, human behavior, organizational behavior, interpersonal relations, and communications. Ability to identify, build, maintain, motivate, lead and inspire teams to achieve high team performance and to meet the project’s objectives. Ability to create an environment that facilitates teamwork. Comfortable interacting with individuals at all levels internal and external to UNC Lineberger. Candidate must enjoy working collaboratively with multidisciplinary groups of colleagues. Excellent customer service skills and good judgement required.
Ability to manage multiple projects at various stages, and work independently with occasional guidance from supervisor. Strong organization and problem solving skills required. Must have a demonstrated ability to deliver high quality results on time and to manage competing priorities. Demonstrated ability to analyze trends and evaluate data suggesting process improvements. Strong software and computer skills, including MS Office applications required.
Lineberger Comprehensive Cancer Center’s Clinical Protocol Office is recruiting for 2 Clinical Trial Activation Project Managers (positions 20038017 and 20038018). By applying to this posting you will be considered for both positions.
Posting Close Date: 04/15/2021