Reg & Start Up Spec 2 (R1119055) in Durham, NC at IQVIA™

Date Posted: 2/14/2020

Job Snapshot

  • Employee Type:
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements either at the global, regional, or country level.
Prepares and manages site regulatory documentation; reviews and negotiates site regulatory documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of regulatory and contractual documents for sites; ensures contracts are fully executed; and establishes project timelines.     

     Essential Functions
•    Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
•    Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
•    Prepare site regulatory documents, reviewing for completeness and accuracy.
•    Review, prepare and negotiate site contracts and budgets with sites, if applicable.
•    Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
•    Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
•    Review and provide feedback to management on site performance metrics.
•    Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
•    May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
•    May assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.
•    May provide input into contract and budget template development.
•    May support importation activities.
•    May have direct contact with sponsors on specific initiatives.
•    May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
•    May act as mentor, and prepare and deliver country-specific training, for less experienced staff.
•    May participate in feasibility and/or site identification activities.
•    May perform Site Selection Visits if a trained monitor.
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.
Typically requires 2 - 3 years of prior relevant experience.
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.              
Skills and Abilities    
    In-depth knowledge of clinical systems, procedures, and corporate standards.        
    Good negotiating and communication skills with ability to challenge, if applicable.        
    Effective communication, organizational, and interpersonal skills.        
    Ability to work independently and to effectively prioritize tasks.        
    Ability to manage multiple projects.        
    Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.        
    Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.        
    Understanding of regulated clinical trial environment and knowledge of drug development process.        
    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
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

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

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 to arrange for such an accommodation.

Job ID: R1119055