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Job Description

At Thermo Fisher Scientific, you’ll 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.

Role-related skills

Excellent technical/IT skills. Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of systems/software.
Knowledge of relevant operational procedures, systems and quality guidelines regarding clinical studies.
Able to work independently as well as in a team.
Professional attitude with good customer focus (internal and external).

Role Responsibilities

Maintain up to date participating center’s information (including all contact details, contracts and reports).
Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. Assist study staff with maintaining the sponsor files during the life of the study. Responsible for archiving at the end of study in accordance with relevant SOPs, policies and local regulatory requirements.
Input and oversee clinical study tracking systems.
Proactively identifies issues and raises them to study staff to take necessary corrective action to ensure smooth and rapid progress of studies.
Assist in the planning, logistics and preparation of local Investigator meetings (travel arrangements, assist with preparation and distribution of study related presentation material etc.).
Responsible for working with the study staff for the management of study materials, non-IMP and IMP supplies - distribution, ordering, tracking, storage, reconciliation and destruction using external vendor. Details of destruction to be filed.
As an active participant of clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study and be responsible for given tasks.
Assist study staff with study related activities such as:
organizing study meetings and scheduling travel,
producing minutes for study-related meetings,
assembling training and study materials,
updating contact details,
maintaining study documentation,
assisting in the preparation of documents and other tasks as required.
Knowledgeable of systems.
Keep up to date with all the changes/required knowledge on ICH GCP, written standards and attending appropriate training sessions.
May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.
Requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community.