Assoc Regulatory & Start-Up Manager

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.

Provides operational support to the Clinical Research organization to ensure the wellbeing of clinical research subjects and the best possible project outcomes

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

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.

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.