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Assoc Reg & Start-Up Mgr (R1070862) in Durham, NC at IQVIA™

Date Posted: 5/27/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Date Posted:
    5/27/2019
  • Job ID:
    R1070862

Job Description

Join 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.

JOB OVERVIEW
Serve as Site Start-Up (SSU) lead for project(s) or programs. Lead SSU team by providing operational strategy and parameters for review/negotiation of contracts and regulatory documents.  May be assigned to manage the site start-up activities for a country or region within a global trial. May participate in feasibility and/or site identification activities.

Responsibilities
     Essential Functions
•    Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:
•    Serve as SSU lead within region for project(s) or programs or service line.  Lead SSU team or service line in all the activities.  Monitor team efficiency and adherence to project timelines, budget and SOPs and WIs.
•    Maintain and manage SSU data tracking entries in database.  Review for completeness and accuracy.
•    Review and provide feedback to management on site performance metrics.
•    Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for start up.  Review and negotiate regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
•    Serve as central contact for investigative sites, designated project reports, and customer service.
•    Resolve site issues and determine status for product shipment.
•    Work with regulatory team members or sponsor to secure authorization of regulatory documents.
•    Work with legal team members or sponsor to secure authorization of contracts.
•    Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
•    Where applicable, provide work instructions to team members in preparation of regulatory submissions.
•    Facilitate process improvement efforts both within the department and in cooperation with other departments.
•    May be assigned as ad hoc member to various process improvement working groups.
•    Participate in sales presentation and proposal development; may provide input into budget development.
•    Participate in mentorship and training of less experienced staff.
•    May be assigned contract review responsibilities.
•    May represent department at internal and external presentations including sponsor audits.
•    May translate or review completed translations of critical documents.
•    May participate in feasibility and/or site identification activities.
 
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 2 - 3 years of prior relevant experience.
 
Knowledge
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
 
Education
Education Level    Education Details    Req    Pref     
Bachelor's Degree    Related field     X         
 
Additional Work Experience
Experience Details    Req    Pref     
5 years clinical research experience, including 1 year experience in a leadership capacity    X         Or
Equivalent combination of education, training and experience    X         
 
Skills and Abilities
Skill/Ability    Description    Proficiency     
    In-depth knowledge of clinical systems, procedures, and corporate standards        
    Strong knowledge of medical terminology and regulations        
    Broad knowledge of clinical research        
    Strong knowledge of Microsoft Office and e-mail applications        
    Effective communication, organizational, and interpersonal skills        
    Effective presentation skills        
    Effective leadership skills        
    Ability to work independently and to effectively prioritize tasks        
    Ability to delegate        
    Ability to manage multiple projects        
    Attention to detail        
    Ability to establish and maintain effective working relationships with coworkers, 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
Physical Demand    N/A    Rarely    Occasionally    Frequently    Constantly
Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.                   X     
Use hands and fingers to handle and manipulate objects and/or operate equipment.                   X     
 
Travel Requirements
Frequency    Brief Description
Occasional    
 
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

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™

QVIA 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.



Job ID: R1070862