Clinical Project Manager (Early Clinical Development, Home-Based)

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 and procedures set forth by IQVIA Biotech and sponsors. Supports the department director in development of functional training, 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 scope.Reviewing 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 every instance of out of officeKNOWLEDGE, SKILLS AND ABILITIES:Knowledge of clinical research process from Phase I through regulatory submissionStrong communication skills (verbal and written) to express complex ideasExcellent 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 various 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 captureWorking 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 a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization with at least one (1) year management experience OREquivalent level of education and experience. Previous experience in managing people within a scientific/clinical environment is preferred.Clinical Monitoring or Data Management experience required. Excellent and demonstrated verbal and written communication and presentation skills. Ability 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. Experience in contract/timeline management preferredExcellent written and verbal communication skills requiredAbility to travel domestically or internationally as requiredCLASSIFICATION: US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.SummaryLocation: Overland Park, KS, United States of America; Florissant, Missouri, United States; Port Huron, Michigan, United States; Belmar, New Jersey, United States; Lafayette, Louisiana, United States; Warren, Ohio, United States of America; Liverpool, New York, United States; Jackson, Michigan, United States; Abington, Pennsylvania, United States; Florence, Kentucky, United States; Abingdon, Virginia, United States; Bloomington, Indiana, United StatesType: Full time