Senior Clinical Trial Associate

Req #: 1803515
Location:Marin, NeuchatelCH
Job Category:Clinical Operations
Work Location: Champs Montants 14A MARIN 2074
Organization: Celgene R&D Sarl
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Marin

Description

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.

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:

• 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