Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start
Caring. Connecting. Growing together.
Positions in this function provides project level input and coordination, including; clinical study feasibility analysis, site identification, recruitment projections, enrollment monitoring, data collection status, data progress and strategy, data lock tracking and overall reporting of metrics.
Job Components
- Clinical Study Management
- Project Management
- Clinical Research Best Practices
You’ll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough challenges.
Primary Responsibilities
- Provides project level input and coordination, including; clinical study feasibility analysis, site identification, recruitment projections, enrollment monitoring, data collection status, data progress and strategy, data lock tracking and overall reporting of deliverable and timelines
- Leads, directs and executes clinical studies in accordance with approved clinical strategy, project plans, budget and resources in compliance with applicable regulatory requirements and standard operating procedures
- Establishes and maintains successful collaboration and partnerships with customers, Contract Research Organizations (CROs), third party vendors, study investigators and site research personnel to facilitate successful execution of clinical studies
- Supports development and maintenance of internal and external clinical study materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions
- Ensures the clinical project team maintains a continuous state of audit readiness
- Leads proactive identification, assessment, and management of clinical study risks
- Facilitates strategic decisions to optimize implementation of projects specific to the management of scope, financials and schedule
- Anticipates project risks and develops mitigation strategies/plans to address more complex risk factors
- Provides guidance to Clinical Data Managers on individual study requirements and ensures operational consistency across assigned clinical trials
- Presents and communicates study progress to senior level clinical and business leadership
- Reviews active projects in OpenAir for alignment to project contract, generates and approves invoices
- Performs monthly budget reconciliations for customer projects and analyzes resource utilization trends to forecast resourcing needs and increase budget accuracy
- Identifies and utilizes most current SOPs, WPs, POLs and Forms as required by each project type
- Assists with deck creation for external life science customers and maintains brand compliant base template
- Uses tact and diplomacy to resolve conflicts across project team members and customers
- Demonstrates advanced knowledge and understanding of project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed
- Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff
You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
Required Qualifications
- Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas. Advanced degree desirable (e.g., MS, MBA, PhD, MPH, PharmD)
- 5+ years of project management experience preferably using MS Project and/or other project management tools
- 5+ years of clinical study experience, (e.g., pharmaceutical, medical device, IVD, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, complex studies
- 2+ years of experience working with customers and vendors
- Knowledge of clinical trial concepts and practices, including clinical research guidelines
- Knowledge and understanding of project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed
Preferred Qualifications
- Proven ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment
- Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences
- Proven ability to learn and adapt to new software tools and technology
- Proven ability to work effectively in a virtual environment
- Attention to detail: Identifies and resolves source data discrepancies with accompanying written documentation
- Communication, verbal: Conveys thoughts in a clear, concise, and accurate manner. Uses correct grammar. Listens carefully and asks questions when necessary to ensure understanding
- Communication, written: Conveys findings in a clear, concise, and accurate manner. Monitoring reports and follow-up letters require few clarifications or editions by project team
- Computer literacy: Uses computer hardware and software as productivity tools in performing work-related tasks. Enters information into company-required tracking programs with minimal outside assistance.
- Customer service: Provides customers (Sponsors/Clients and site personnel) with complete and accurate information. Quickly identifies needs and follows through on commitments made. Maintains a high energy level when interacting with customers. Demonstrates professionalism and presents a positive image of the company
- Development of self and others: Identifies personal career development goals and opportunities related to current job with assistance of regional manager. Seeks additional training and assistance with additional responsibilities and feedback on performance
- Planning & organizing: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. Has a routine or system for completing work. Consistently meets timelines. Proactively notifies manager of any difficulties with balancing workload
- Problem solving & decision making: Demonstrates ability to make sound decisions. Focuses on resolving problems and makes decisions in a timely manner. Promptly notifies project team of the problem and any decisions made
- Relationship building: Maintains positive relationships with site personnel and colleagues. Demonstrates honesty and integrity in dealing with others. Resolves conflicts with others promptly and effectively. Accepts constructive feedback
- Technical knowledge: Displays full knowledge of protocol, regulatory requirements, and company Standard Operating Procedures (SOPs). Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety. Distinguishes between good practice and regulatory requirements. Applies knowledge into practice on-site
- Therapeutic knowledge: Portrays good knowledge of the disease under study. Discusses the disease with site personnel and colleagues. Comprehends medical information received. If new therapeutic indication, learns the vital aspects of the disease without major difficulty
- Work habits: Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties. Meets timelines and follows up without being prompted. Plans travel time well and makes effective use of time
- All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy
The salary range for this role is $89,800 to $176,700 annually based on full-time employment. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you’ll find a far-reaching choice of benefits and incentives.
Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.
Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.
