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.
BMS hires Clinical Trial Associate
in Istanbul, Turkey.
In this role your main job 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
- Contract & budget negotiations as per established BMS guidance
- 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 auditpreparation & Corrective Action / Preventative Action preparation for local related issues
- F luency in English & Turkish languages is essential
- Degree within Life Sciences area, Administrative, Financial or Accounting related field (preferred)
- 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
- 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
- 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
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.