New · posted Nov 5
Thermo Fisher Scientific · Pharmaceuticals
Clinical Data Associate II (Early Development)
- Remote, US
- Remote
- Full-time
- Associate & Specialist
The role
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.
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.
What you need
- 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.
What you'll do
- 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
Schedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Office
Job intelligence
The context around this role
Live data · November 5, 2026
Career trajectory
Where this role sits in Clinical Data Management
The general path across 62 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 38 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems6
- Collaboration and leadership5
- Documentation and SOPs4
- Validation and qualification3
- Clinical trial conduct3
- Lab testing and methods1
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Data Management work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA require
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 123
- Open roles
- 109
- Distinct roles
- 48
- Locations
By discipline
- Quality77 63%
- Clinical40 33%
- Regulatory6 5%
By level
- Senior & Principal52 42%
- Associate & Specialist38 31%
- Manager27 22%
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Clinical Data Associate II (Early Development) at Thermo Fisher
Open until filled.