Senior Director, Regulatory & Start-Up (Site Activation) (R1097347) in Durham, NC at IQVIA™

Date Posted: 11/13/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    11/13/2019
  • Job ID:
    R1097347

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.

Job Family Description

Provides operational support to the Clinical Research organization to ensure the well-being of clinical research subjects and the best possible project outcomes.

Sub-Family  Description

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. 

JOB OVERVIEW

Job Profile Summary

Direct Site Management operations for a designated (sub-) region or a defined function within the (sub-) region. Develop plans to ensure the allocation of human, material, system and fiscal resources for assigned area of accountability. Determine strategic goals and objectives for designated (sub-) region and/or function ensuring operational alignment with senior management priorities. Lead (sub)-regional and/or functional strategic initiatives and work with senior management across disciplines to develop implementation plans.

Responsibilities

 

•Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.

•Direct the hiring and selection process for a function/ (sub-) region or office and work collaboratively with senior management to set targets for recruitment and retention across roles.

•Contribute to the formulation of effective strategic goals for Site Management operations across (sub-) regions. Take ownership for strategic initiatives within assigned unit of accountability including development of measures for success.

•Provide leadership to ensure service offerings meet or exceed customer expectations. Ensure the improvement of the execution of Site Management processes.

•Manage operational delivery to achieve outputs to pre-defined targets.

•Contribute to the provision of strategic leadership and approval for the resourcing process and outcomes, hiring targets and processes and on-boarding and training standards.

•Provide a leadership role in resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with Site Management leadership and operational peers.

•Evaluate regional/functional workload, quality and budget metrics through regular review and reporting of findings. Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for Site Management projects.

•Act as a coach and mentor for managers as they develop in their role. Work collaboratively with client representatives and other functional (site management) leadership to manage project related challenges and to achieve exemplary customer service.

•Pro-actively plan for appropriate Site Management operations budget consumption and guide line managers in managing variances and in developing corrective fiscal action plans.

•Effectively communicate and describe all Site Management service offerings to internal and external customers.

•Ensure quality and regulatory appropriateness and acceptance of all service offerings.

•Lead corporate or departmental quality or process improvement initiatives. Act as a client liaison for Site Management function.

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 a minimum of 10 years of prior relevant experience.

Knowledge

Requires broad management and leadership knowledge to lead multiple job areas, the ability to influence others to accept practices and approaches.

Education

Required: Bachelor's Degree

Preferred: Bachelor’s degree, preferred in Healthcare or other scientific discipline and 15 years of clinical trials experience including

8 years experience in a leadership capacity utilizing general management practices desirable (e.g. The Oz Principle, The

4 Disciplines of Execution); or equivalent combination of education, training and experience.

Skills and Abilities

  • Knowledge of the drug development processes and in depth knowledge of Site Management processes and practices.
  • Expert ability to analyze metrics and information; ensuring activities and strategies are data driven
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Knowledge of clinical research financial parameters and project financial tracking and accounting methods
  • Strong leadership skills
  • Effective presentation skills
  • Strong written and verbal communication skills including good command of English
  • Excellent organizational and problem solving skills
  • Effective time management skills and ability to manage competing priorities
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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 workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1097347