Study Start Up Specialist (UK, homebased), IQVIA Biotech

IQVIA; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading global clinical research company is looking for a Study Start-Up Specialist. The role involves leading complex projects, ensuring compliance with regulations, and managing site activation. Candidates should have a Bachelor’s degree in life sciences and at least three years of clinical research experience. Strong communication, organizational, and interpersonal skills are essential. Join us in creating a healthier world through innovation and collaboration.

Benefits

Access to innovative technologies

Collaborative work environment

Exposure across various studies

Qualifications

• 3 years of clinical research experience, including 1 year in a leadership role.
• In-depth knowledge of clinical systems and corporate standards.
• Good negotiating and communication skills.

Responsibilities

• Lead complex projects as Single Point of Contact for studies.
• Ensure adherence to standard operating procedures and project timelines.
• Perform feasibility, site ID, startup, and site activation activities.

Skills

Clinical research experience

Negotiating skills

Effective communication

Organizational skills

Interpersonal skills

Ability to prioritize tasks

Knowledge of GCP/ICH guidelines

Education

Bachelor's Degree in life sciences

Job description

Study Start-Up Specialist

IQVIA Biotech

UK Homebased

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

• As a Study Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
• You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.
• You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.
• You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.
• Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.
• You may also act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role.

Qualifications and Skills

• Bachelor's Degree Bachelor’s Degree in life sciences or a related field
• 3 years clinical research experience, including 1 year experience in a leadership capacity.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• In-depth knowledge of submissions for UK and Ireland
• EUCTR knowledge
• Good negotiating and communication skills with ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage 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.

Join IQVIA and let’s create a healthier world together:

• Exposure across 21 Therapeutic Areas
• Be part of a global team who operate across 141 locations
• Exposure across a variety of studies and projects
• Access to new, innovative technologies
• Work within a collaborative and vibrant environment
• Own your career!

Unleash your potential!

It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.

When you join our diverse, global team, you’ll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com