Clinical Trial Associate

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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.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
• 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:

• 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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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