Clinical Data Associate II(Early Development) - Remote U.S

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Summarized Purpose:

Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical

devices.

• Remote based United States
• Must be legally authorized to work in the United States without sponsorship.

• Must be able to pass a comprehensive background check, which includes a drug screening.

Essential Functions:

• Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.
• Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.
• Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.
• Produces project-specific status reports for CDM management and for clients on a regular basis.
• Performs data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews

Education and Experience:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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 and ability to use interactive computer programs
• Good written and verbal communication skills and a strong command of English language and grammar
• Good organizational and analytical/problem-solving skills
• Ability to work productively with moderate supervision
• 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, adaptability and ability to work in a team environment or independently as needed
• Must demonstrate good judgment in making decisions
• Knowledge of medical/clinical trial terminology
• Understands project protocol and Data Validation Manual

Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.

Physical Requirements:

• Frequently stationary for 4-6 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.