Marin, Neuchatel, Switzerland Job Category:
Clinical Operations Work Location:
Champs Montants 14A 2074 Organization:
Clinical Trials Employee Status:
Full-time Job Type:
Celgene is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first.
At the core of that mission are the talented individuals who contribute their unique skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team.
What unique gene will you bring to Celgene?
In our Clinical Operations team, we deliver our mission by ensuring operational execution of clinical studies, and that they are on-time, in budget, and high quality.
As the Senior Clinical Trial Associate, you will support that goal by collaborating with the Clinical Trial Manager and by being responsible for participating in cross-functional study teams (as to work towards high-quality clinical trials).
Responsibilities involve a combination of execution and oversight, dependent upon the sourcing model, to ensure study deliverables are met and may include, but are not limited to, the following:
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- Provide operational input on development, management and maintenance of study deliverables
- Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
- Working within compliance regulations (ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs)
- Lead / Participate in monitoring visit report review process
- Support Health Authority inspections and CQA audits as required
- Ensure full compliance of the required data in study management tools
- Proactive identification of potential risks and development/implementation of actions
- Develop and maintain collaborative relationships with internal and external partners/stakeholders
- Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution
- Participate in vendor specification development and management/oversight
- Manage TMF set-up, ongoing quality review, and final reconciliation
- Reconcile IP at study level
- Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes...)
- Contribute to development / coordination of study training
- Contribute to ordering and distribution of materials as required
- Manage study-level IP shipment to sites
- Manage collection, review and tracking of study documents as necessary
- Assist with Investigator meeting coordination and planning
- Assist with compilation of Clinical Study Report appendices
- Manage vendor and site payment processing and tracking
- Assist with maintenance of study budget tracking tools and reconcile invoices
- Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Strong oral and written skills with proficiency in English
- Demonstrates analytical approach and anticipation of problems
- Ability to multi-task effectively and prioritize assignments from multiple sources
- Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
- Excellent organizational skills
- Strong knowledge of MS applications
- Knowledge of drug development process
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.