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Associate Director, Regulatory & Start-Up (Qcare) (Based in Raleigh-Durham, NC) - (1804027) in United States at IQVIA™

Date Posted: 2/14/2018

Job Snapshot

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.

Description

PURPOSE 

Develop and implement department procedures and manage overall team/directs activities for the central Regulatory and Start-Up (RSU) activities for the Qcare network..  Lead a team to ensure that all start-up requirements (documents, budgets, contracts) are created and finalized for Qcare sites.  Work closely with Qcare local site staff and legal teams to ensure site needs are addressed in contracts.  Ensure that site budgets are created in accordance with site needs. Ensure all activities are documented in Qcare CTMS system.  Work closely with CRO RSU staff to ensure expedited start-up processes for site start-up.  Function as part of the Qcare leadership team to ensure the network is successful and meets corporate objectives.   A law degree is preferred but not required. . 

RESPONSIBILITIES

  • Oversee the team that will deliver the entire start-up process for Qcare sites working on both IQVIA studies and non-IQVIA studies.
  • Assist in formulation of strategic initiatives and work with functional management to develop implementation plans, including regulatory and start-up evaluation measures.
  • Interface with Qcare contacts to determine operational strategy and/or expectations and parameters for key deliverables.
  • As needed, provide Proposal Management with input on proposals and budget development for Qcare components of projects. Attend proposal defenses as needed.
  • Liaise with sites and clients to ensure operational efficiency; implement updates to processes to ensure maximum efficiency and customer satisfaction.
  • Review and analyze performance metrics and processes to provide input in the development and implementation of process/system improvements.
  • Work closely with Qcare finance to ensure financial reporting is efficient and accurate.
  • Accountable for employee departmental efficiency and adherence to standard operating procedures (SOPs), Work Instructions, and project instructions and timelines.
  • Manage employees in accordance with organization’s policies and applicable laws. Responsibilities include planning, assigning and directing work of employees; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions for all management / human resource matters.
  • Assist with audits and provide recommendations and assist in the implementation of Corrective Action Plans.
  • Resource employees efficiently to ensure achievement of utilization and realization targets.
  • Manage the selection and on-boarding process for new employees by conducting candidate review and participating in the interview process. Ensure employees have the appropriate materials, systems access and training to complete job responsibilities.
  • Support team to ensure that they successfully complete mandatory Compliance and GCP training and pass related exams. 

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Full knowledge of the drug development process
  • Full knowledge of applicable regulatory requirements, Standard Operating Procedures (SOPs), and company’s Corporate Standards
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Excellent knowledge of budget management and resourcing
  • Considerable working knowledge of medical terminology
  • Strong knowledge of Microsoft Office and e-mail applications
  • Effective communication, organizational, interpersonal, and leadership skills
  • Excellent negotiating skills
  • Ability to lead and motivate teams
  • Ability to independently coordinate and manage new processes
  • Ability to handle management/personnel issues
  • Ability to work independently and to effectively prioritize tasks
  • Ability to work within a matrix team environment
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients 


MINIMUM REQUIRED EDUCATION AND EXPERIENCE 
  • Bachelor’s degree, preferred in Healthcare or other scientific discipline and 10 years of clinical trials experience including 6 years’ experience in a leadership capacity, a broad understanding of general management practices desirable (e.g. The Oz Principle, The 4 Disciplines of Execution); or equivalent combination of education, training and experience. 


PHYSICAL REQUIREMENTS
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time. 
  • May require occasional travel 


EEO Minorities/Females/Protected Veterans/Disabled

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™.


Job ID: 1804027