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.
We are seeking a Clinical Trial Associate to join our high performing team, well regarded for their global contribution to clinical studies. This position will manage the administrative and business activities related to the conduct of clinical trials (registrational and non- registrational /Investigator Sponsored Research Studies) with investigative sites from study start-up to study closure.
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 file.
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.
External: Clinical Study Sites, Institutional Review Boards/Ethics Committees, Vendors, Contract Research Organizations, GCP Officer (China only).
Internal: Protocol Manager (PTM), Clinical Trial Managers (CT Mgrs) Clinical Trial Monitors (CTMs), Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Line Managers, Heads of Clinical Operations and Local Regulatory .
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.
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.
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).
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 ).
BMS offers flexible work arrangements with a 50:50 split remote and office.
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.