Associate Director, Clinical Research

  • Anywhere

Company :
Novartis Pharmaceuticals

Location :
East Hanover, New Jersey

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

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Description :
Associate Director, Clinical Research BR Job ID: BR Job Description: 20 Novartis associates in the US make up the Scientific Alliances and Clinical Science Operations team. We are a team of dedicated and passionate people who embrace the importance of our work and the impact we make on patients. We have an immediate need for an Associate Director, Clinical Research. This leader will support US efforts in the planning, execution and reporting of US Oncology Medical (USOM) clinical trials in Oncology/Hematology/CART/RLT Your responsibilities include, but are not limited to: 1. Responsible for end to end implementation and management of designated clinical programs/trials. Track and manage key trial indicators including: monthly project status, key deliverables to senior management. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems. 2. Serve as clinical program lead / trial leader for US Medical Affairs Trials (including Phase I-IV, Managed Access, Investigator Initiated, Registries, Research Collaborations). Interface with the oncology therapeutic area global and U.S. clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas 3. Support the development, management and tracking of trial budgets working closely with the appropriate partners. 4. Manage the Contract Research Organizations and other vendors – initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success. 5. Support all scientific aspects of clinical trial(s) and program level activities as assigned. 6. May provide management to the clinical research scientists to ensure that their role and contribution are optimized. nnnn Position Title: Associate Director, Clinical Research Minimum requirements: What you’ll bring to the role: – Bachelor’s degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution. – 7+ years clinical research or research monitoring experience that provides the required knowledge, skills and abilities and experience mentoring or training others. – Effective clinical trial management/monitoring skills along with an excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures. – Ability to mentor and train other clinical scientists in a positive and effective manner and the ability to evaluate clinical trial data and proficient knowledge of medical terminology. – Effective oral and written communication skills, with the ability to communicate effectively with medical personnel. – Effective oral and written skills. 799 million, that’s how many lives our products touched in 2019. While we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Imagine what you could do at Novartis! Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: Job Type: Full Time Country: USA Work Location: East Hanover, NJ Functional Area: Research & Development Division: ONCOLOGY Business Unit: ONCOLOGY BU Employment Type: Regular Company/Legal Entity: Novartis Pharmaceuticals EEO Statement: _The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._ Shift Work: No