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Clinical / Senior Clinical Trial Associate within Medical Affairs Operations

05.03. | Employee | 100%

Clinical / Senior Clinical Trial Associate within Medical Affairs Operations

Share This Page Clinical / Senior Clinical Trial Associate within Medical Affairs Operations Medical and Regulatory Affairs Boudry, , Switzerland Full time R1521670_EN 2/14/2020 10:06:24 AM Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. As we approach a critical time in our quest to deliver medical innovation, we are seeking a forward-thinking and self-sufficient Clinical Trial Associate to join our Global Medical Affairs team . Focussing on late-phase studies, you will work cross-functionally as to progress projects whilst also collaborating with the respective Study Manager - this will principally involve contributing to the operational execution of Medical Affairs Sponsored Trials (interventional and/or non-interventional) as to ensure that the trials are completed on time, within budget, and in compliance with applicable regulations, guidelines, SOPs and WPs (as well as providing high-quality data). In return, you will be joining a dynamic environment, where you will play a crucial part in a Global team, whilst also building your knowledge / experience of innovative studies within a fast-moving biopharma organisation. Depending on experience, this hire can be made as Senior Clinical Trial Associate - for that to happen, you would be able to demonstrate prior "industry" experience (from either a pharma/biotech organisation or from vendor-side / CRO), as well as prior case studies from similar roles and relevant examples from when you have worked in an international environment (with "global" exposure). Responsibilities Study Conduct Support the Study Team to select potential investigators and assess their interest in the study Participate in vendor management/oversight activities Participate in monitoring report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans Process drug shipments after gathering necessary essential documents and track the receipt of shipments if required. Reconcile IP at study level. (for interventional studies) Contribute to development / coordination of study training for study team, investigational sites, and vendors Contribute to the oversight of the required country regulatory and country/site IEC approvals/notifications Support Health Authority inspections and CQA audits as required Study Documentation Ensure full compliance (completeness & accuracy) of the required data in study management tools including CTMS, patient enrollment forecasting, etc. Manage TMF set-up, ongoing quality review, and final reconciliation Assist with the collection of various study documents such as country/site insurance, CSR appendices Have a significant role in managing the study documentation including: - Distribute and, at times, create study documents for the study sites such as confidentiality agreements (CDA), feasibility questionnaires, study binders, etc. - Maintain and track documents such as Investigator Brochures (IBs), insurance policies, documents that are expiring and IND safety letters - Collect, quality review and submit documents to the Trial Master File (TMF) - Perform quality control of the TMF as appropriate - Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with Contract Research Organizations (CROs) and other vendors - Generate, finalize and distribute study team agendas and meeting minutes Financial Management Process and track payments to vendors and study sites as appropriate Assist with maintenance of study budget tracking tools as required Added Responsibilities (depending on Experience) M o d er a t e f u n c t i o n a l i m p ac t o n t h e s t u d y t eam M a n a g e s m u lt ip l e ass i g n m e nt s w ith su p erv i s io n P a r t i c i p a t e s i n s e rv i c e p r o vi d e r o v e r s i ght P r o v i d es u pd a tes f o r f un c t i o n a l a r e a Buil d s relat i on s h i p s t o ac h ie v e i n f l u e n ce w ith o t h e rs Education and Experience You will possess at least a Bachelor's degree, within a Life Sciences field - it is advantageous to possess a MSc but not essential You will be able to demonstrate experience from within a pharmaceutical / Clinical Research Organisation domain As someone who is adept at working within a matrix environment, you will have proven communication skills and an ability to work independently You will have a positive mindset, embrace challenges, and also be able to trust the actions / advice of others It would be advantageous for you to have w o r k i n g k no w led g e o f ICH / G C P guidelines 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 the resources to pursue their goals, both at work and in their personal lives. Working with Us By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move. Come Meet Our Team Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. For US Applicants Only Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. For our EEO Policy Statement, please . If you'd like more information on your EEO rights under the law, please click here: and Follow Us Powered by

05.03.2020
Employee, 100%

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Celgene, A Bristol Myers Squibb Company

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Celgene, A Bristol Myers Squibb Company

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896

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Training Company
Training Company

Celgene, A Bristol Myers Squibb Company

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896

Labels (1)

Training Company
Training Company
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