Clinical Quality Study Lead

Work Schedule

Environmental Conditions

Job Description

Join Us as a Clinical Quality Study Lead - Make an Impact at the Forefront of Innovation

Locations considered: Serbia Poland Hungary and Bulgaria

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

The Clinical Quality Study lead provides Clinical Quality oversight and support to the clinical study teams.

You will pro-actively implement quality principles during the clinical design and set-up study conduct and reporting providing continuous support and input during the Clinical Development Activities in the GCP area.

What Youll Do:

• Provide Quality principles and quality insights to the study team at study design and start up.
• Act as the first point of contact for any quality related questions/ concerns for study teams
• Own the Quality role on study level by providing continuous quality compliance support by acting as an internal advisor to the study team on relevant processes procedural documents and regulations to ensure correct interpretation and implementation.
• Ensure alignment with client quality and the quality agreement and is the conduit to consult with client on study quality issues and investigational strategies to ensure transparency of direction.
• Lead the quality oversight for assigned clinical studies in close collaboration with the study team.
• Provide guidance to the clinical study team to ensure clinical studies are executed and compliant to GCP and local regulatory requirements.
• Support the design of study risk management plans and the definition of appropriate risk responses QTLs; helps to mitigate quality compliance risks.
• Coordinate and support in GCP audits as needed
• Lead in collaboration with study teams inspection readiness activities and participates in inspections

Knowledge Skills Abilities:

• Ability to co-exist in 2 organisations and navigate organisational structures and dotted line reporting line(s) to achieve clear communication and transparency.
• Indepth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines.
• Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements.
• Ability to motivate and educate the clinical study team on clinical quality aspects.
• Capable of building effective relationships with internal and external stakeholders.

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.