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.
• 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