Clinical Trial Associate

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This position manages administrative and business activities to support the regulatory and procedural requirements necessary for US investigative trial sites to conduct clinical trials, with accountability of executing these activities from study start-up to study closure.

Key Responsibilities

Setting up vendors during study start up period (operational details from sites)

Enter necessary data / tracking in systems (i.e.ECLIPSE, eTMF, SAP)

Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like Mytrials/Shared Investigator Portal) including conduct of completeness checks

Arranging drug and non-drug (Lab kits, ECG) importation to support study site

Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO

Collect and distribute documents from / to sites during study life cycle

Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation

Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding

Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)

Obtain Insurance certificates

Preparing On Site Investigator File and other study related files

Support equipment calibration and tracking

Archiving process handling at study closure

May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval. This could include preparation and/or submission of substantial amendments.

May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB)

May support Health Authority inspection and pre-inspection activities

May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

Minimum Requirements:


Bachelor’s degree in nursing, life science or healthcare related field or equivalent work experience

1-3 years’ experience in clinical research or related work experience





Knowledge of ICH/GCP Guidelines and local regulatory guidelines or regulations preferred

Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent.


Ideal Candidates Would Also Have:


Additional complex software application related to clinical trial research (i.e. electronic data capture or patient diaries, interactive voice response, etc…)


Other qualifications:


US military experience will be considered towards industry experience requirements


Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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