Celgene Sr Clinical Trials Associate in Summit, New Jersey
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 Sr. 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 and Duties:
Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders
Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
Lead / Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans
Support Health Authority inspections and CQA audits as required
Ensure full compliance (completeness & accuracy) of the required data in study management tools including CTMS, patient enrollment forecasting, etc.
Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
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 in collaboration with IMSC
Actively contribute to study meetings including: presentation, subject matter expert, generate, finalize and distribute study team agendas and meeting minutes, etc.
Contribute to development / coordination of study training for study team, investigational sites, and vendors
Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
Contribute to ordering and distribution of materials as required
Manage study-level IP shipment to sites
Support the development/coordination of study training materials for study team, investigational sites, and vendors in conjunction with study manager
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 with overall contract/budget and finance reports
Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.
May perform other assigned tasks as required
Degree in relevant discipline
Solid experience in pharma/CRO/healthcare
Solid knowledge of drug development process
Basic project management skills
Intermediate knowledge of ICH/GCP and local guidelines, regulations and directives
Offer suggestions and contributes to discussion regarding milestones and deliverables.
Excellent oral and written skills and ability to effectively apply these skills
Advanced computer technical skills
Working knowledge of budgets, finance and clinical trials
Strong oral and written skills with proficiency in English
Knowledge of ICH/GCP and regulatory guidelines/directives
Demonstrates analytical approach and anticipation of problems
Identifies gaps and provides constructive feedback and solutions
Ability to multi-task effectively and prioritize assignments from multiple sources
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
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.