Celgene Sr Clinical Trials Associate in Summit, New Jersey

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.

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

Minimum Requirements:

  • 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

#LI-POST

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.