Site Management Center (SMC) Manager, Late Phase Research - i3 Innovus - Reston,

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Company:
 		UnitedHealth Group
Company Profile | Current Opportunities (75)
Job Location(s): Statewide
Employment Term: Regular
Employment TypeFull Time
Start Date:As soon as possible
Starting Salary Range:Not Provided
Required Experience: Open
Related Categories:Management and Supervision, Healthcare - Administration/Billing

Position Description

Job Description - Site Management Center (SMC) Manager, Late Phase Research - i3 Innovus - Reston, VA / West Chester, OH / Cary, NC (313485)
Job Description
Site Management Center (SMC) Manager, Late Phase Research - i3 Innovus - Reston, VA / West Chester, OH / Cary, NC-313485
Description
SMC Manager
i3 Innovus - Late Phase Research
Reston, VA - West Chester, OH - Cary, NC
i3 Innovus is a leading provider of health economics and outcomes research and market informatics solutions to help clients realize the full potential of their brands. As an international organization that counts among its clients most of the top 20 biopharmaceutical companies in the world, i3 Innovus has a world-class reputation in econometrics and outcomes data analysis and leads the globe in providing research solutions to support market access and reimbursement of health care products. i3 Innovus delivers real-world evidence that demonstrates the value to help products succeed in the market.
As a UnitedHealth Group company, i3 Innovus is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Innovus can provide.
The SMC Manager will be involved in all aspects of research activities within the i3 Site Management Center (SMC). Perform or oversee all aspects of phase IV/registry/prospective research projects from inception to completion within the SMC which include but are not limited to: site management activities, recruitment of study investigators, regulatory document and site contract collection, Institutional Review Board (IRB)/Ethic Committees (EC) submissions, and Prepare and implement quality assurance of study deliverables and site materials.
Primary Responsibilities
  • Provide input to proposal teams, as it relates to the SMC, to develop competitive proposals that can be delivered to meet time, quality and financial expectations of i3 Innovus and the Sponsor
  • Participate and present at bid defense meetings.
  • Prepare and implement quality assurance of study deliverables and site materials.
  • Manage project budgets and timelines, as it relates to the SMC, to include milestone planning and tracking.
  • Manage client relationships.
  • Perform vendor selection and management functions when required by project scope.
  • Participate in the recruitment/selection of Late Phase In-House CRAs, performance management, training, mentoring and employee relations, as required.
  • Provide support, performance management and career development guidance to direct reports.
  • Recognize the need to seek assistance or inform senior management of specific issues.
  • Monitor and implement quality assurance activities within the SMC.
  • Ensure adherence to protocol, SOPs, applicable GCP/ICH/GEP Guidelines, applicable regulatory requirements, and other documentation requirements.
  • Contribute to the development and refinement of standard operating procedures, working practices, process flows, and infrastructure for the SMC.
  • Contribute to the growth and development of the department through participation in and leadership of process and tool development, initiatives, and management.
  • Other duties as assigned by supervisor.
Qualifications
Qualifications:
  • Undergraduate degree and a minimum of 3 years of relevant work experience or postgraduate degree in a related field and minimum of 2 years of relevant experience.
  • Experience in Late Phase or Consumer Health preferred.
  • Demonstrated success in meeting project time, quality and financial targets in a matrix organization.
  • Training and/or experience in the health care delivery field.
  • Training and/or experience in clinical development process and/or outcomes research.
  • Demonstrated ability to successfully supervise and lead others
  • Established ability to communicate effectively, both verbally and in writing.
  • Established ability to work independently and as part of a team.
  • Thorough knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Excellent relationship building and interpersonal skills
  • Excellent organizational skills and ability to prioritize and multi-task
  • Proficient in Microsoft Office Applications
Diversity creates a healthier atmosphere: an equal opportunity employer, M/F/D/V. UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.
Job Project Mgmt - Pharma Research
Primary LocationUS-Virginia
Organization i3 Innovus - North America
Schedule Full-time
Number of Openings 1

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