Regulatory & Start Up Manager (Avacare Contracts Legal Analyst)

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 description (overview)
  • Under general supervision, serve as Single Point of Contact (SPOC) for escalation, review, and negotiation of agreements for assigned Site Service project sites.
  • Provide contracting intelligence to support assigned studies and the wider company, as required.
  • Accountable for overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
  • Assess and review the contracting landscape and lead the collection, interpretation, analysis and dissemination of accurate guidance to operational contacts, including identification of legal requests vs. business decisions
  • Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Accountable for specialist legal, operational and financial contracting support provided by the team to ensure efficient
  • Inform team members of completion of contractual documents for individual sites. 
  • Review, track and follow up the progress, the approval and execution of documents in line with project timelines.
  • Support the delivery of activities as determined by the appropriate team lead and conducts specific tasks under guidance of senior staff.
• Helpful experience/skills (What we look for when filling these positions)
  • Strong interpersonal communication and organizational skills
  • Good attentional to detail and ability to work on multiple projects
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Experience negotiating with or on behalf of Investigator Sites for Clinical Research
  • Excellent negotiating and legal writing skills.
  • Effective communication, organizational, planning and interpersonal skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to work within a matrix team environment 
  • Ability to work on 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.
  • Proven ability to work on multiple projects balancing competing priorities

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.