Clinical Study Start Up Specialist

Abbott; Witney; On-site; GBP 40,000 - 70,000; Full time

Job description

Abbott is seeking a highly skilled and motivated Clinical Study Start-Up Specialist to join our dynamic team. This role is crucial for managing all aspects of clinical study start-up across multiple countries, ensuring effective study commencement and compliance with country-specific regulations and guidelines.

About Us: At Abbott, we help people live more fully at all stages of life. Abbott is about the power of health. For more than 130 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Main Responsibilities:

• Manage and execute study plans from an operational perspective to ensure effective study commencement.
• Ensure all activities supporting study approvals are performed according to study plans and country-specific regulations.
• Maintain a detailed understanding and application of all country-specific study requirements and standard start-up timelines.
• Act as the "expert-in-the-field" for country start-up activities.
• Be part of global project teams involved in business-critical clinical programs, including new product development, pivotal, and post-launch studies.
• Maintain the effectiveness of the ADC Quality System in accordance with divisional and corporate requirements and applicable regulations.
• Develop site feasibility/assessment strategies to ensure site engagement and meet patient recruitment expectations.
• Maintain a database of site feasibility assessments and site performance metrics.
• Develop and maintain good working relationships with clinical, regulatory, statistical teams, and other internal customers, including senior management.
• Contribute to the development and testing of systems (e.g., EDC, CTMS) from a study end-user perspective.
• Plan and coordinate internal and external meetings (e.g., Investigator Meetings, DMC).
• Assist in the identification and selection of vendors (e.g., CRO, laboratories).

Qualifications:

• B.Sc. in Life Sciences or related field.
• Extensive experience in leading multiple phases and stages of clinical operations.
• Monitoring and/or site/study management experience.
• Knowledge of global regulations and standards affecting clinical trials.

Skills and Competencies:

• Strong understanding of country-specific study requirements and timelines.
• Excellent communication and interpersonal skills.
• Ability to develop and maintain relationships with internal and external stakeholders.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong problem-solving and risk mitigation skills.
• Ability to mentor and support junior staff within the Clinical Affairs organization.

Why Abbott? At Abbott, we are dedicated to advancing healthcare and improving lives. Join us and be part of a team that is committed to making a difference. We offer a dynamic work environment, opportunities for professional growth, and a chance to contribute to ground-breaking clinical research.

In addition to a competitive salary, Abbott offers a highly attractive benefits package which includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme which you can tailor to your own requirements.

The base pay for this position is N/A.

JOB FAMILY: Clinical Affairs / Statistics

DIVISION: ADC Diabetes Care

LOCATION: United Kingdom > Witney : Range Road

WORK SHIFT: Standard

TRAVEL: Yes, 10 % of the Time