Manager, Project Management and Activation
University Code 32911 University Title Administrator 1, Research University Job Family Research & Innovation ORP Eligible Yes For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Job Series Scope of Search Regional Working Title Manager, Project Management and Activation Position Number 592760 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Massey Cancer Center Organizational Overview
At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.
Position Primary Purpose and General Responsibilities
The Manager, Portfolio Management and Activation group oversees all aspects of the start-up and activation administrative process and project management for clinical trials from trial concept review, initial receipt of CDA through the start-up and activation of the trial. S/He is accountable and responsible for the activation team moving all trials through the activation
process in a timely and efficient manner. Ensures the protocol portfolio for each Disease Working Group is up to date, and is accurately and timely communicated to the CTO Clinical Operations team leads, Regulatory, Research Finance and the DWG clinical program lead/co-leads as well as other partners throughout the VCU and VCUH research enterprise such as
OVPRI, CRO, OSP .
As a manager within the Massey Cancer Center Clinical Trials Office ( CTO ) the incumbent is accountable for providing regulatory expertise, demonstrating project management acumen, managerial and strategic leadership to the Portfolio Management and Activation group and
throughout the Clinical Trials Office. S/he manages and develops a team of 7 direct report Activator Coordinators assigned within the group and collaborates with the training and education, regulatory and clinical research operation units to ensure new or revised process improvements initiatives are adequately communicate to the Clinical Trials Office and throughout Massey and the Virginia Commonwealth University ( VCU ) Enterprise as appropriate.
S/he establishes and implements standard procedures that:
(1) proactively detect compliance, eliminates and prevents regulatory compliance issues;
(2) minimize institutional risks; institutes continuous process improvements
(3) identifies areas for process improvement and ensures new process are integrated
into the standards;
(4) enables the Activation team to hit target center goals and metrics 75% of the time;
(5) reduces time to completion and minimizes workload for all stakeholders;
(4) maximizes cost recovery and efficiency.
S/he serves as the subject matter expert on best practices in project management, six-sigma, start-up and activation process at MCC and works closely with the Director Regulatory, Activation and Quality Control, Information Technology analytics and reporting group, the Cancer Center Informatic Core and other CTO and VCU / VCUH partners to respond to data
requests and deliverable. S/He will ensure compliance to FDA, HHS regulations, ICH and CCSG guidelines, policies and procedures and ensures adherence to applicable regulations, SOPs, working guidelines and the study protocol. The incumbent will occasionally be required
to step in and do the work of activation Coordinator, will ensure training, education and development of the team and ensure even distribution of workload.
This position reports to the Director, Regulatory Affairs of the MCC CTO and works collaboratively to develop, implement, and maintain the infrastructure necessary to support National Cancer Institute ( NCI ) designation.
Minimum Hiring Standards
Bachelor’s Degree required and at least 3 years as an Activation Coordinator at a NCI designated Cancer Center or academic health system, or 5+ years of clinical research experience activating complex clinical trials with 2 years of leadership level experience or evidence of progressive leadership experience (leading the implementation of new process improvement initiatives).
Demonstrated knowledge and experience in the following areas are required:
• Activation and start-up activities within an academic health system, cancer center.
• NCI CCSG knowledge regarding TTA benchmarks for NCI designated Cancer Centers
• Coverage analysis, Disease Area Working Groups, Scientific Review Committee and the workflow for these items within the overall start-up and activation process.
•Extensive knowledge in FDA, ICH regulations governing clinical research
•Strong communication skills (verbal and written)
•Ability to provide leadership and promote collaboration
•Possess exceptional time management skills
•Excellent interpersonal skills with transferable service and support skills
•Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU .
Preferred Hiring Standards
•Knowledge and/or experience with NCI CCSG expectations is preferred.
•Previous experience coordinating and managing clinical trials or conducting all aspects of study start-up and activation for oncology clinical trials
•Project Management experience and knowledge
•Professional Organization certification preferred (SoCRA, ACRP, PMI ) completion of CITI training, GCP knowledge
Required Licenses/ Certifications Anticipated Hiring Range commensurate with experience Application Process/Additional Information Campus MCV Campus Hours/Week 40 Normal Work Days/Hours 8-5, M-F Job Open Date 06/01/2021 Posting will close on or before Open Until Filled Yes Job Category Is this a restricted position? No Is this position eligible to participate in alternative work arrangements? Yes Sensitive Position No Resource Critical Yes Quick Link https://www.vcujobs.com/postings/106520 Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Please describe your experience with clinical research.
(Open Ended Question)
- * Describe your experience with regulatory compliance for
(Open Ended Question)
- * Describe the types of time management skills you use and why
they are effective?
(Open Ended Question)
Required Documents Optional Documents
- Cover Letter/Letter of Application
- Other Document