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Fsp - Regulatory Start Up Specialist & Contract Negotiator

1+ years
Not Disclosed
10 Jan. 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Site Activation Specialist
Company: IQVIA
Location: [Insert Location]

Job Overview

We are seeking a Site Activation Specialist to perform tasks associated with site activation activities at a country level. The role involves ensuring compliance with local and international regulations, standard operating procedures (SOPs), and project requirements. The position may also include maintenance activities to support the overall project lifecycle.

Essential Functions

  • Act as a Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management teams, and other departments for assigned studies, ensuring adherence to SOPs and project timelines.
  • Perform start-up and site activation activities, distributing completed documents to sites and internal teams as needed.
  • Prepare and review site regulatory documents for completeness and accuracy, ensuring proper compliance.
  • Maintain accurate project information in internal systems, databases, and tracking tools.
  • Provide feedback to management on site performance metrics and help track progress against project timelines.
  • Monitor the approval and execution of documents such as regulatory submissions, ethics approvals, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents.
  • Support planning and monitoring measures, implementing contingency plans as needed to meet project deadlines.
  • Offer local expertise to SAMs and project teams during project timeline planning and management.
  • Ensure quality control of documents provided by sites and escalate issues where needed.
  • Potentially engage directly with sponsors on specific initiatives or project deliverables.

Qualifications

  • Bachelor's Degree in Life Sciences or a related field.
  • At least 3 years of clinical research experience, including experience in regulatory, submissions, and contract negotiations, with at least 1 year in a leadership capacity.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Strong negotiation and communication skills with the ability to provide constructive feedback when necessary.
  • Ability to manage multiple projects and prioritize tasks effectively.
  • Familiarity with GCP/ICH guidelines and regulatory requirements, including local regulations and SOPs.
  • Ability to maintain effective working relationships with internal teams, clients, and stakeholders.
  • Knowledge of the drug development process and the regulated clinical trial environment.

About IQVIA

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We drive intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.

Learn more at IQVIA Careers.