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.
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Summarized Purpose:
Performs all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.
Key responsibilities:
- Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.
- Reviews data listings for accuracy and consistency of data.
- Acts as point person and subject matter expert for specialized study-specific processes.
- Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required.
- Contributes to the improvement of data management processes on a global level.
- Produces project-specific status reports for management and/or clients on a regular basis.
- Provides training and work direction to junior staff as required.
Keys to Success
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
Knowledge, Skills and Abilities:
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
- Strong attention to detail and skill with numbers
- Good written and verbal communication skills
- Good analytical/problem-solving skills
- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Strong customer focus and excellent interpersonal skills.
- Proven flexibility and adaptability
- Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands
- Knowledge of medical/clinical terminology
- Understands project protocol and DVM
- Proven track record in achieving applicable technical proficiencies per the DM proficiency grid
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!