Job Title: Clinical Project Management

　　Location: Indianapolis, Indiana (Onsite)

　　Shift: Monday-Friday 8-5

　　Type: Contract One Year

　　Pay: $38/hour

　　Notes: Interacting with a team in Cork Ireland

　　Must Haves:

　　Bachelor’s degree, preferably in a scientific or health-related field

　　Minimum of 5 years’ experience in the pharmaceutical industry and/or clinical development

　　Early phase clinical trials operations experience preferred, but not required

　　Must understand clinical development processes and the interdependencies of various tasks that require coordination among asset team, functional/regional team members and third parties

　　Demonstrated core project management skills through management of

　　complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guideline

　　Must be capable of managing cross-functional staff in Cork, Ireland

　　Additional Skills/Preferences: Project management certification (e.g., PMP), previous supervisory experience, prior experience in working with a pharmaceutical business partner (e.g., CRO, Alliance, Joint Venture

　　Travel may be required

　　Responsibilities:

　　Clinical Planning and Execution: Role-based Training Plan (Clinical Operations

　　Accountable for oversight of clinical operations and delivery of clinical project milestones on time and on budget

　　Create and manage implementation timeline and clinical trial activities via a custom database and Project Management tool

　　Accurately forecast and track direct expenses for clinical budget

　　Document key team information and clinical decisions in Chorus custom tracking and communication database

　　Manage clinical operational risks and their impact to the timelines and budgets of clinical studies, including critical path activities

　　Select and manage external network of vendors to ensure on time and on budget clinical project deliverables

　　Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward

　　Partner with regulatory and medical to ensure safety management and monitoring processes are implemented

　　Provide input into molecule development, clinical regulatory and safety strategy

　　Manage global cross-functional communication and escalations to ensure alignment on delivery and execution

　　Participate in review of clinical database specifications and utilization

　　Manage the writing and approval of informed consent documents

　　Leadership: Role-based Training Plan (Chorus Line Management)

　　Ensure direct report competencies evolve and address implications to overall resource management and strategies. People Management: Role-based Training Plan

　　Recruit, develop and retain a diverse and highly capable workforce Benefits

　　System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.