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Clinical Trial Manager

2 months ago

Solna Municipality, Sweden IQVIA Full time
Clinical Trial Manager Job Description

Job Summary:

We are seeking a highly skilled Clinical Trial Manager to join our team at IQVIA. As a Clinical Trial Manager, you will be responsible for providing local management of clinical trials in a country or countries, ensuring high-quality data and trial documents/records that are compliant with regulatory requirements.

Key Responsibilities:

  • Operational oversight of assigned projects at the country level, from start-up through to closeout activities.
  • Ensure local trial teams are delivering high-quality data and trial documents/records that are compliant with assigned clinical trial protocols, company SOPs, ICH-GCP, and regulatory requirements.
  • Partner with the Clinical Program Leader, Global Clinical Trial Support MAO, and Global Trial Leader MAO to ensure overall study delivery at the country level.
  • Deliverables will adhere to applicable sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
  • Comply with relevant training requirements.
  • Prepare or contribute to high-level budget estimates in response to Request for Service's followed by detailed budget proposals.
  • Ensure overall contract management, including review and approval of external service provider contracts, change orders, and ensures services are delivered per contract.
  • Act as primary company contact for assigned trials at the country level and ensures local/country teams are tracking project progress against planned timelines and monitors patient recruitment rates to ensure target enrollment will be met across allocated countries.
  • Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
  • Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
  • Escalate corrective and preventive actions (CAPA) to GTL MAO and CPL when trials deviate from plans and communicate study progress and issues to study management teams and business partners.
  • Contribute to site-level recruitment strategies and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.
  • Deliver competent vendor management at the country level to support studies and may submit requests for vendor services and support vendor selection.
  • Manage local study drug supplies as required.
  • Contribute to patient understanding of protocols and patient safety by contributing to the review of country-specific informed consent in accordance with procedural documents/templates.
  • Ensure trial subject safety by reporting all AEs/SAEs/PQCs within required reporting timelines and documenting as appropriate.
  • Ensure inspection readiness by maintaining complete, accurate, and timely data and essential documents in systems utilized for trial management (e.g., CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
  • Work closely with GTL MAO, CPL to ensure CAPA is implemented for audits/inspections or any quality-related issues or concerns.
  • Ensure accurate finance reporting and trial delivery within budget by adhering to finance reporting deliverables and timelines.
  • Keep trials in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
  • May contribute as a mentor, champion, or representative of functional areas in process initiatives, as required and if applicable.

Requirements:

  • BA/BS degree in a health or science-related field.
  • Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO.
  • Strong working knowledge of ICH-GCP, company SOPs, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
  • Strong IT skills in appropriate software and company systems.
  • Excellent decision-making and string financial management skills.
  • Proficient in speaking and writing the country language and English.
  • Good written and oral communication skills as appropriate.
  • Flexibility and ability to manage study teams in a virtual environment.

About IQVIA:

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.