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.
Summary / Scope :
The 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 :
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