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. The Clinical Trial Associate (CTA) will manage administrative and business activities related to the conduct of clinical trials with investigative sites from study start up to study closure. The CTA plays a vital role in supporting the activities of the Regional Clinical Operations and will join an energetic and supportive team. Responsibilities Setting up vendors during study start up period (operational details from sites). Enter necessary data / tracking in systems (i.e.CTMS, eTMF, SAP). Responsible for documentation within the eTMF (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 Payment Due Reports, creating fund/PO, managing, tracking and executing payments and closing country/investigational site funds. Collect and distribute documents from / to sites during study life cycle. Coordinate study related documents (i.e., IB, Protocol, Site Informed Consent Forms, etc.) for printing and binding. Provide administrative support to the study team (i.e., study related mailing, bill processing, printing etc.) Obtain Insurance certificates. Complete debarment checks Preparing On Site Investigator Files and other study related files. Support equipment calibration and tracking where required. Archiving process handling at study closure. Support distribution of Additional Label Forms (ALF) to sites May support and/or prepare ethics/regulatory submissions 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. Qualifications, experience and competencies Degree within Life Sciences area, Administrative, Financial or Accounting related field. 1 - 3 years' experience in Clinical Research or related work experience. Our ideal candidate would have experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent & Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc…) 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 time-frame, 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. Software that must be used independently and without assistance(Microsoft Suite, Clinical Trial Management System (CTMS),Electronic Trial Master File System (eTMF),Document Exchange Portals). To protect the safety of our employees, third parties, customers, patients and communities, BMS Australia requires all employees to be fully up to date (Boostered) with vaccination status using a locally approved vaccination against COVID-19, unless an exemption is applicable under the State or Federal legislation relevant to you (e.g. your state’s anti-discrimination act). Within our policy an exemption can only be approved by the HR Director. By applying for this role, you understand that you will be asked if you can comply with the Policy
LI-Remote “ Please be aware that BMS Australia is bound by certain global commitments that may affect the appointment of this position.” 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.