Clinical Trial Associate

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

JOB DESCRIPTION SUMMARY

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 startup to study closure.

Key Responsibilities and Major Duties

• Setting up vendors during study startup period (operational details from sites)
• Enter necessary data / tracking in systems (i.e.CTMS, eTMF, SAP)
• Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like 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

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

• Key Stakeholders/Contacts - describe this position’s key internal matrix relationships and key external stakeholders/clients
• External: Clinical Study Sites, Institutional Review Boards/Ethics Committees, Vendors, Contract Research Organizations, GCP Officer (China only)
• Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) Clinical Trial Monitors (CTMos), Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Line Managers, Heads of Clinical Operations and Local Regulatory

DEGREE REQUIREMENTS:

Bachelor’s degree within Life Sciences area, Administrative, Financial or Accounting related field preferred or minimum 2 years working experience in any of these areas in addition to high school degree or local equivalent.

Experience Requirements:

• CTA: 1 - 3 years’ experience in Clinical Research or related work experience.
• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent preferred
• Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc…) preferred

Key Competencies:

• Basic understanding of GCPs, ICH Guidelines and local regulations as they apply.
• Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
• Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.
• Demonstrates ability to function independently
• General knowledge of software systems and web-based applications. Good computer aptitude and willingness to learn new systems and applications.
• Good verbal and written communication skills (both in English and local language).
• Microsoft Suite
• Clinical Trial Management System (CTMS)
• Electronic Trial Master File System (eTMF)
• Document Exchange Portals

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Key Responsibilities and Major Duties

• Setting up vendors during study startup period (operational details from sites)
• Enter necessary data / tracking in systems (i.e.CTMS, eTMF, SAP)
• Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like 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 issue

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

• Key Stakeholders/Contacts - describe this position’s key internal matrix relationships and key external stakeholders/clients
• External: Clinical Study Sites, Institutional Review Boards/Ethics Committees, Vendors, Contract Research Organizations, GCP Officer (China only)
• Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) Clinical Trial Monitors (CTMos), Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Line Managers, Heads of Clinical Operations and Local Regulator