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Senior Clinical Project Manager, Cardiovascular/Renal/Metabolic (Home/Office-Based) – IQVIA Biotech (R1059161)

IQVIA

This is a Contract position in Morrisville, NC posted June 12, 2019.

Job DescriptionJoin us on our exciting journey IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.BASIC FUNCTIONS:Responsible for the successful planning, implementation and execution of contracted activities.

Assures the accurate transfer of contracts from proposal through project completion.

Functionally responsible for all team members throughout the duration of each clinical trial.

Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by IQVIA Biotech and sponsors.

Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:Responsible for all activities related to implementation of clinical studies including:Manages projects of full scope regional and global projects.

Responsible for project team leadershipResponsible for building and maintaining positive client relationshipsAbility to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained, projects are done within scopeReviewing and identifying project study trends and proactively responding to client and respective team membersDeveloping appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challengesIdentifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirementsResponsible for change management on all assigned projectsResponsible for assuring projects assigned are run according to SOPs and WP as refined in the contractResponsible for assuring project timelines are met as per contractResponsible for identifying processes which need updating and documenting that to the direct line manager or divisional leadResponsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is awareIn conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.Provide other project support to Managers, as assignedOversee delegation of support staff activities, as necessaryAssists in the development and delivery of capability and proposal defense presentations to prospective clientsSupports Contracts and Proposals with final project contract execution and CIS documentation by the project team.

Represents senior management in negotiation of contracts as appropriate.Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annuallyMaintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.Responsible to maintain personal currency documentation for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of officeKNOWLEDGE, SKILLS AND ABILITIES:Thorough knowledge of clinical research process from Phase I through regulatory submissionStrong communication skills (verbal and written) to express complex ideasExcellent and demonstrated organizational and interpersonal skillsPositive attitude and ability to interact with all levels of staff to coordinate and execute study activitiesAbility to manage multiple priorities within a variety of complex clinical trialsAbility to reason independently for the purpose of assessing and recommending specific solutions in clinical settingsAbility to set baseline targets, track trends and implement mitigation plansUnderstanding of basic data processing functions, including electronic data captureDemonstrated problem-solving and financial negotiation skills Working knowledge of current ICH GCP guidelinesCRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:Very limited physical effort required to perform normal job duties.Up to 20% travel may be required including international travelMust be able to secure a credit card cosigned by IQVIA BiotechMINIMUM RECRUITMENT STANDARDS:Previous Management Requirements:Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with at least five (5) years direct clinical trial experience in a CRO or research-related organization with at least two (2) years management experience OREquivalent level of education and experience.

Previous experience in managing people within a scientific/clinical environment is required.Demonstrated Clinical Monitoring and/or Data Management experience required.

Excellent verbal and written communication and presentation skills required.Demonstrated financial management skills requiredAbility to work independently, prioritize and work with in a matrix team environment is essential.

Working knowledge of Word, Excel, and PowerPoint required.

Prior experience in electronic data capture preferred.

Ability to travel domestically or internationally as required.CLASSIFICATION: US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.We know that meaningful results require not only the right approach but also the right people.

Regardless of your role, we invite you to reimagine healthcare with us.

You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there We invite you to join IQVIA™IQVIA is an EEO Employer
– Minorities/Females/Protected Veterans/DisabledIQVIA, Inc.

provides reasonable accommodations for applicants with disabilities.

Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruitingiqvia.com to arrange for such an accommodation.Job ID: R1059161 Employee Type:Full-TimeLocation:Morrisville, NCDate Posted:6/10/2019Job ID:R1059161