Sr. Virtual Trial Study Lead (Remote)

JOB OVERVIEW
Manage the execution of the assigned medium to large multi regionally-based clinical studies per Contract from initiation through to closeout.  Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies, and practices.

Responsibilities
     Essential Functions
•    Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.  Ensure consistent use of study tools and training materials and compliance with standard processes, policies, and procedures.  Implement continuous improvement activities for assigned projects.
•    Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance
•    Serves as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to
•    Report on team performance against contract, customer expectations, and project baselines to management
•    Lead problem solving and resolution efforts to include management of risk, contingencies and issues.  Develop proactive contingency plans to mitigate clinical risk.
•    Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans.  Escalate findings and manage study issues and obstacles.
•    Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
•    Provide input for the development of proposals for new work and project budgets
•    Provide input to line managers of their project team members performance relative to project tasks.  Recommend team members further professional development, Support staff development, and mentor less experienced CPMS.
•    Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of the CRA team
•    Prepare and present project information at internal and external meetings
•    Participate in proposal development.  May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff
•    Define project workload and assignments.  Develop and oversee maintenance of internal databases and project plans.  

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience
Typically requires 3 - 5 years of prior relevant experience.

Knowledge
Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

Education 
Bachelor's Degree  / Life sciences or related field              

Additional Work Experience 
7 years clinical research experience including 4 years project management experience  
Equivalent combination of education, training and experience  

Skills and Abilities  
    In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines  
    In depth therapeutic and protocol knowledge  
    Strong communication and interpersonal skills, including good command of English language        
    Strong organizational and problem solving skills        
    Demonstrated ability to deliver results to the appropriate quality and timeline metrics        
    Good team leadership skills        
    Effective mentoring and training skills        
    Excellent customer service skills        
    Good judgement  
    Effective presentation skills        
    Ability to manage competing priorities  
    Strong software and computer skills, including MS Office Applications  
    Ability to establish and maintain effective relationships with workers, managers, and clients        

Standard ADA Settings
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Standard ADA Selection     Office Environment

Physical Demands
Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.                    
Use hands and fingers to handle and manipulate objects and/or operate equipment.  

Travel Requirements
May require occasional travel.

The above information on this description has been designed to indicate the general nature and level of work performed.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job.  While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, 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_recruiting@iqvia.com to arrange for such an accommodation.