Director Clinical Operations at UnitedHealth Group in North Carolina
UnitedHealth Group Inc.North Carolina
Director Clinical Operations, Digital Research Network - Telecommute
Combine two of the fastest-growing fields on the planet with a culture of performance, collaboration and opportunity and this is what you get. Leading edge technology in an industry that's improving the lives of millions. Here, innovation isn't about another gadget, it's about making health care data available wherever and whenever people need it, safely and reliably. There's no room for error. Join us and start doing your life's best work.(sm)You'll join a high caliber team where you're assisting, educating, problem - solving and resolving tenuous situations to the best possible outcomes. Bring your people skills, emotional strength and attention to detail. Get ready to start doing 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* Oversee deliverables to support program objectives as defined in the clinical development plan; identify risks, communicate risk mitigation plans, and escalate risks and risk mitigation strategies
* Support expansion of DRN operations to out-of
- US clinical sites via knowledge and experience of international research processes and regulations
* Partner with the clinical data and analytics team and clinical data managers on acquisition of feasibility results, precision patient finding lists, and clinical study database development
* Create and manage development plans and budgets for planned and ongoing trials for presentation to DRN Leadership
* Line management responsibilities include performance development and mentorship to clinical study managers and the study support team
* Ensure that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
* Participate in developing and drafting clinical trial protocols, study amendments, study specifications, data requirements, informed consent forms, and other documents as needed or requested
* Support Healthcare Organization recruitment identification, outreach, and processes
* High level oversight of trial data acquisition, i.e., flow from the EHRs at the sites to data entry (CRF's entered in database) to data listing review
* Responsible for ensuring team compliance with SOPs and supporting documents, FD
A regulations and current ICH GCP guidelines
* Partner with the Optum Compliance team during client audits of documents, internal systems and/or vendors; ensuring compliance with GCP, GxP, CFR Part 11, HIPAA and other applicable domestic and global regulatory requirements.
* Collaborate with clinical staff to develop and support departmental initiatives to ensure operational consistency across multiple programs
* Develop work processes which enhance the cross functional effectiveness of clinical operations with other functions such as clinical/medical, tech team, data management, regulatory, finance, legal and business developmentYou'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* Bachelors' Degree or Master's degree in relevant field (e,g, Life sciences, MPH, MSc and advantage)
* Minimum of 5 years of knowledge around drug / device development and applicable regulations
* Minimum of 5 years' experience in clinical operations gained in a biopharmaceutical company or Contract Research Organization
* Minimum of 2 years of experience managing a team and developing and updating Standard Operating Procedures
* If you need to enter a work site for any reason, you will be required to screen for symptoms using the Protect.
Well mobile app, Interactive Voice Response (i.e., entering your symptoms via phone system) or a similar United.
Health Group-approved symptom screener. When in a United.
Health Group building, employees are required to wear a mask in common areas. In addition, employees must comply with any state and local masking orders.
Preferred Qualifications* Prior experience of global clinical studies
* Ability to understand budgets and produce resource forecastsIf you're the kind of thinker and leader who wants to bring your contribution to a new level every day, bring yourself over to Optum. You'll discover an opportunity to do your life's best work.(sm)Diversity creates a healthier atmosphere: United.
Health 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. United.
Health Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. Job Keywords: Director, Clinical Operations, Healthcare, United.
Health Group, Telecommute
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