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Work Schedule

Other

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

Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

Discover Impactful Work:

Associate Clinical Research Manager assists with managing various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between senior project team members and study subjects. Actively participates and assists with sponsor, investigator and research team communications.

A day in the Life:

Actively participates with senior project team members to meet project needs, projections and deadlines.

Oversees organization and accuracy of project documents.

Works with management on understanding departmental needs and improving processes.

Provides support for the study conduct, working directly with study monitor and study subjects.

Oversees data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review and subject eligibility notification

Keys to Success:

Education

Associate's degree degree or equivalent and relevant formal academic / vocational qualification

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Knowledge, Skills, Abilities

Basic knowledge of Phase I processes and clinical study operations

Fundamental knowledge of FDA regulations and ICH GCP guidelines

Basic computer skills with working knowledge of Microsoft Office applications

Time management and multi-tasking skills

Written and verbal communication skills

Ability to prioritize workload and adapt to changing study needs

Ability to act as a liaison between external and internal groups

Physical Requirements / Work Environment

Work is performed in an office/ laboratory and/or a clinical environment.

Exposure to biological fluids with potential exposure to infectious organisms.

Exposure to electrical office equipment.

Personal protective equipment required such as protective eyewear, garments and gloves.

Ability to work in an upright and /or stationary position for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

Frequent mobility required.

Occasional crouching, stooping, with frequent 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.

Frequently interacts with others to obtain or relate information to diverse groups.

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.

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!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.