Clinical Study Manager - Telecommute

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UnitedHealth Group
Analysis, Biotechnology, Data Collection, Development, Director, Genetic, Manager, Management, Materials, Medical Device, Project, Project Management, Research
Full Time, Full-time
Competitive
Telecommuting available Travel not required

Job Description


Challenge brings out the best in us. It also attracts the best. That's why you'll find some of the most amazingly talented people in health care here. Bring your skills and talents to a role where you'll have the opportunity to make an impact on a huge scale. This is the place to do your life's best work.(sm)

You'll enjoy the flexibility to telecommute* from anywhere within the U.S. as you take on some tough challenges.


Primary Responsibilities:


Provides project/trial level input and coordination, including; feasibility analysis, recruitment projections, data collection status, data progress and strategy, data lock tracking and overall reporting of deliverable timelines
Leads, directs and executes clinical studies worldwide 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 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 projects specific to the management of scope, financials and schedule
Anticipates project risks and develops mitigation strategies/plans for more complex risk factors
Provides guidance to Clinical Data Managers working within assigned program and ensures operational consistency across assigned clinical trials
Presents and communicates study progress to senior level clinical and business leadership
Uses tact and diplomacy to resolve conflicts across project team members and customers
Manages relationships with sites/PIs and other study related vendors, including CRO's
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
Experience with various CTMS systems


Required Qualifications:


Bachelor's degree, preferably in the life sciences, clinical or other relevant technical areas
5+ years project management experience preferably using MS Project and/or recent proven success within a BD product development core/extended team
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
Knowledge of clinical trial concepts and practices, including clinical research guidelines
Experience working in a cross matrixed environment and presenting/communicating with a variety of levels
Strong client and vendor relationship management skills
Must be able to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment
Based on location, must be willing and able to work in a virtual environment


Preferred Qualifications:


Advanced degree (e.g., MS, MBA, PhD, MPH, PharmD)

Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.(sm)

*All Telecommuters will be required to adhere to UnitedHealth Group's Telecommuter Policy.

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.

Job Keywords: pharma, Pharmaceutical, clinical study, clilnical studies, clinical trial, telecommute, telecommuting, telecommuter, work from home, travel, remote, wfh


Job Title: Clinical Study Manager - Telecommute
Shift: Day Job
Travel: No
Business: Optum Analytics
Family: Analytics
Telecommuter Position: Yes
Job Level: Director
Overtime Status: Exempt
Posted Date: 1/17/2019
City: Eden Prairie
State: MN
Country: United States
Department: Optum Analytics Operations

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Company Information

We have modest goals: Improve the lives of others. Change the landscape of health care forever. Leave the world a better place than we found it. Such aspirations tend to attract a certain type of person. Crazy talented. Compassionate. Driven. To these individuals, we offer the global reach, resources and can-do culture of a Fortune 14 company. We provide an environment where you’re empowered to be your best. We encourage you to take risks and in return, offer a world of rewards and benefits for performance. Exceeding your limits is an exceptional start to your life's best work.(SM) Just like you, we are driven by a set of fundamental principles that are guiding our way forward. Our values of integrity, compassion, relationships, innovation, and performance serve as a foundation to transform health care. Are you in? Learn more about your future at UnitedHealth Group at http://careers.unitedhealthgroup.com
Dice Id : uhgbot
Position Id : 794786

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