Bristol Myers Squibb에서 우리는 과학을 통해 환자의 삶을 변화시키는 단일 비전에서 영감을 받았습니다. 종양학, 혈액학, 면역학 및 심혈관 질환과 업계에서 가장 다양하고 유망한 파이프 라인 중 하나 인 우리의 열정적 인 동료들은 의미있는 변화를 주도하는 혁신에 기여합니다. 우리는 우리가 개척하는 모든 치료에 인간의 손길을 가져옵니다. 우리와 함께하고 변화를 만드십시오.
Purpose/Objective of the job
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.
List of minimum requirements
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Degree within Life Sciences area, Administrative, Financial or Accounting related fieldCTA: >1 year experience in Clinical Research or related work experience
Sr. CTA: 3 or more years' experience in Clinical Research or related work experience
Competencies – knowledge, skills, abilities, other
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 skills/experience requirements (e.g., Microsoft Suite):
Microsoft Suite
Clinical Trial Management System (CTMS)
Electronic Trial Master File System (eTMF)
Document Exchange Portals
Key Responsibilities and Major Duties
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 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
전 세계적으로 우리는 심각한 질병을 앓고있는 환자의 삶에 영향을 미치기 위해 열정적입니다. 포용적인 문화에서 우리의 개인 재능과 다양한 관점을 적용 할 수있는 권한을 부여받은 우리의 열정, 혁신, 긴급 성, 책임, 포용성 및 성실성의 공유 가치는 각 동료의 최고의 잠재력을 이끌어냅니다.
Bristol Myers Squibb은 업무 환경에서 균형과 유연성의 중요성을 인식하고 있습니다. 우리는 직원들에게 직장과 개인 생활에서 목표를 추구 할 수있는 자원을 제공하는 다양한 경쟁 혜택, 서비스 및 프로그램을 제공합니다
