Celgene Clinical Trial Coordinator in Marin, Switzerland
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Here is an opportunity for an organised, flexible, diligent individual for a Clinical Trial Coordinator to join a dynamic, international team - in this role, you will provide in-house support and assistance to assigned study teams within Global Trial Management & Monitoring (GTMM).
(Please note: For headcount reasons, this is a 12-month fixed-term contract position)
Good written and oral communications skills with understanding of written and oral English, uses different communication methods appropriately
Excellent organizational and administrative skills
Experience supporting study teams
Self-starter and proactive self-learner
Hold self-accountable for actions and results
Ability to multi-task effectively and prioritize assignments from multiple sources
Ability to work with limited day to day supervision
Ability to function productively in a fast paced and rapidly changing environment, demonstrate flexibility
Ability to resolve routine problems independently and escalate to management appropriately
Identifies and/or supports new solutions, opportunities, and initiatives to improve products, services, and work processes
Maintains high quality while meeting deadlines and commitments
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint, Outlook
Experience filing paper and electronic study documents, and conducting QC/reviews
Experience with IP reconciliation
SharePoint experience a plus.
CRO or pharma experience - at least 2 years in Clinical Operations preferred with knowledge of clinical trial phases, terminology and functional study team roles.
Responsibilities will include, but are not limited to, the following:
Support study teams in administrative tasks, meeting minutes and logistics
Prepare and track CDAs
Assist with collection and tracking of study documents
Create and maintain Study Document Shared Locations
Assist with TMF set-up, ongoing quality review, and final reconciliation
Send original documents to central TMF, and ensure electronic filing
Support Health Authority inspections and CQA audits as required
Maintain and update data as appropriate in study management tools
Assist with reconciliation of IP
Manage local translations, printing for required local documents
Manage site file binders activities for in-sourced studies
Assist with compilation and QC of Clinical Study Report appendices
Support the development/coordination of study training materials
Support the study specific training matrix
Assist with granting / removing systems and Sharepoint accesses
Run reports from internal databases and display appropriate formatting
Assist with internal and external distribution of IP, documentation, and communication as appropriate
Support the production, coordination, completeness and accuracy of IRB/EC submissions for in-sourced studies
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
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.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE