Thermo Fisher

Clinical Trial Coordinator (fixed term)

Bucharest, Romania Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

Location/Division Specific Information

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. In this role you will be supporting projects of one of your strategic partners, and will be integrated into their teams, processes and systems.

At PPD, part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

Discover Impactful Work:

As a Clinical Trial Coordinator, you will provide technical support to the project team, coordinating non-clinical responsibilities of project administration as applicable to the partners projects.

A day in the Life:

  • Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May utilize local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding phase and provide training to new staff as needed.
  • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
  • Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
  • Ensures allocated tasks are performed on time, within budget and to a high-quality
  • standard. Proactively communicates any risks to project leads.
  • Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
  • Performs administrative tasks on assigned trials, including, but not limited to,
  • timely processing of documents sent to Client (e)TMF as assigned, performing
  • (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.

Keys to Success:

Education

  • University degree, or equivalent in education, training and experience.

Experience

  • Experience of managing multiple projects with differing priorities at one given time

Knowledge, Skills, Abilities

  • Responsible for adhering to Good Clinical Practices, country specific regulations, Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
  • Ability to effectively analyse project specific data/systems to ensure accuracy and efficiency
  • Exceptional communication, collaboration, organisational and time management skills.
  • Fluency in English

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!