Clinical Study Start Up Specialist

0-2 years

Not Disclosed

Willits Witney

10 Feb. 5, 2025

Job Description

Job Type: Full Time Education: B.Sc. 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: Clinical Study Start-Up Specialist
Location: United Kingdom - Witney
Category: Medical and Clinical Affairs

About Abbott

Abbott is a global healthcare leader focused on advancing health and enabling people to live their fullest lives. With over 130 years of experience, Abbott develops life-changing technologies across healthcare, from diagnostics to medical devices. We serve customers in more than 160 countries, creating innovative solutions for all stages of life. Abbott Diabetes Care, based in Witney, is known for revolutionary products like the Freestyle Libre Flash Glucose Monitoring System.

Opportunity Overview

As a Clinical Study Start-Up Specialist, you will play a key role in managing all aspects of clinical study start-up across multiple countries. This includes ensuring study commencement aligns with country-specific regulations and guidelines, and executing study plans effectively.

What You’ll Work On

Study Management: Manage and execute operational plans for clinical studies, ensuring adherence to country-specific regulations.
Country-Specific Compliance: Maintain a deep understanding of country-specific study requirements and timelines, and apply these in the planning stages of clinical studies.
Feasibility and Site Assessment: Develop site feasibility strategies, assess site performance, and ensure patient recruitment goals are met.
Stakeholder Relationships: Build and maintain effective working relationships with clinical, regulatory, statistical teams, and other internal and external stakeholders.
Vendor Selection: Assist in selecting vendors, including CROs and laboratories, for clinical studies.
System Testing and Development: Contribute to the development and testing of clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Quality System Adherence: Ensure that the ADC Quality System meets divisional and regulatory standards.
Team Collaboration: Work as part of global project teams on critical clinical programs, including new product development and post-launch studies.

Required Qualifications

Education: B.Sc. in Life Sciences or a related field.
Experience: Extensive experience in leading multiple phases of clinical operations, with background in monitoring, site, and study management.
Knowledge: Familiarity with global clinical trial regulations and standards.

Skills and Competencies

Study Requirements Knowledge: Strong understanding of country-specific study timelines and regulations.
Communication Skills: Excellent verbal and written communication and interpersonal skills.
Technical Proficiency: Experience using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Problem Solving: Strong ability to mitigate risks and solve problems during the study start-up process.
Leadership: Ability to mentor and support junior staff within the Clinical Affairs team.

Why Abbott?

Abbott is dedicated to improving healthcare and lives through innovative products and groundbreaking clinical research. Join our dynamic work environment, where we offer opportunities for professional growth and development. Benefits include a competitive salary, flexible benefits scheme, private healthcare, pension, share ownership scheme, and various optional initiatives such as yoga and 5k campaigns.

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Clinical Study Start Up Specialist

Job Description

About Abbott

Opportunity Overview

What You’ll Work On

Required Qualifications

Skills and Competencies

Why Abbott?

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