50 days ago on jobs.celgene.com

Senior Clinical Trial Associate (2 Year Maximum Duration Contract)

Celgene Switzerland SA

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Senior Clinical Trial Associate (2 Year Maximum Duration Contract)

Senior Clinical Trial Associate (2 Year Maximum Duration Contract)

Req #:16001643
Location:MARIN, CH
Job Category:Clinical Development
Work Location:Marin, Switzerland Champs Montants 14A Marin 2074
Organization:Celgene R&D Sarl
Shift:Day Job
Employee Status:Limited Term
Job Type: Experienced
Job Level: Individual Contributor

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.


The Senior Clinical Trial Associate (CTA) in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
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:

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
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.


Skills/Knowledge Required:

Degree in a relevant discipline with experience in the Clinical Trial environment (CRA plus in-house experience bonus).
Strong oral and written skills with proficiency in English
Knowledge of ICH/GCP and regulatory guidelines/directives
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