• Assoc Clinical Research Mgr

    ThermoFisher Scientific (Austin, TX)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Able to lift 40 lbs. without assistance, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    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 global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

    Discover Impactful Work:

    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

    Bachelor's 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).

     

    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, 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.

    Physical Requirements:

    + 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.