Bristol-Myers Squibb (BMS) is looking for a Clinical Trials Asso
Bristol Myers Squibb AB / Butikssäljarjobb / Solna
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hela Sverige Visa alla jobb hos Bristol Myers Squibb AB i Solna The CTA is responsible to administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).
Key responsibilities
• To handle all study related administrative taks by utilizes technology effectively to support the clinical trial development processes with the use of Clinical Trial Management System at the Protocol, Country and Site level.
• Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial
• Collaborate with the study project team to reach target within set timelines
• Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
• Set up and maintenance of the Trial Master Files, Electronic filing systems/ set up of the Investigator Site File
• Coordinating archiving of study documentation
• Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites and re-ordering supplies.
• Preparing essential clinical trial documentation, distributing, tracking and filing of documents. on return.
• Understands basic financial analysis of a clinical trial budget and has the ability to track and manage study related contract and payments.
• Effectively uses available tools and systems to gather information needed to manage study activities and to provide feedback to the appropriate BMS team members.
• Identifies potential issues and suggests resolutions. Answers and resolves routine questions independently.
Experience and Skills required:
• High School Degree (University Degree in health sciences, nursing or pharmacy or related field is
desirable)
• At least 2-3 years of experience as CTA in Clinical Research or in the Pharmaceutical Industry
• Knowledge of the Industry/Clinical trial process and drug development and of ICH GCP
• Experienced in multitasking and prioritizing
• Excellent organisational skills and good attention to detail
• Ability to decision making, problem-solve, providing contingency plans
• Able to work with flexibility and independently
• Experienced with IT-technology as e.g. word-processing, presentation graphic, spreadsheet, database, and file management. (ARIBA, ECLIPSE, SAP)
• Good verbal and written communication skills (both in English and Swedish).
Bristol-Myers Squibb is a global BioPharma company firmly focused on its mission to discover, develop and deliver innovative medicines to patients with serious diseases. Around the world, our medicines help millions of people in their fight against such diseases as cancer, cardiovascular disease, hepatitis B and hepatitis C, HIV/AIDS and, rheumatoid arthritis.
At Bristol-Myers Squibb, our BioPharma strategy uniquely combines the reach and resources of a major pharma company with the entrepreneurial spirit and agility of a successful biotech company. With this strategy, we focus on our customers' needs, giving maximum priority to accelerating pipeline development, delivering sales growth and continuing to manage costs. We have delivered 12 new medicines to patients in the past 7 years.
Ultimately, our success as a BioPharma leader is measured by the difference we make in the lives of patients.
Publiceringsdatum2017-01-13Så ansöker duSista dag att ansöka är 2017-01-21
Ange följande referens när du ansöker: Clinical Trials Associate
FöretagBristol Myers Squibb AB
AdressBristol Myers Squibb AB
Box 15200
16715 BROMMA
KontorsadressHemvärnsgatan 9
Jobbnummer 3260232
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