At MediciNova, Inc., we have assembled a highly dedicated world-class group of industry professionals who are committed to making a significant impact through the global development and commercialization of innovative pharmaceutical products that address unmet medical needs in a diverse group of therapeutic areas including asthma, cancer, multiple sclerosis and anxiety disorders.
MediciNova provides an entrepreneurial forward-thinking environment with a strong commitment to teamwork. We offer competitive salaries with an attractive benefits package. Our office, where our employees enjoy a challenging, motivating and exciting atmosphere, is located near the beautiful coastal community of La Jolla.
We seek talented professionals who share a passion for making a contribution to medical advancements that help improve the quality of people’s lives.
MediciNova is an equal employment opportunity employer. If you would like to be a part of our continuing success, please contact us at hr@medicinova.com.
MediciNova offers competitive salaries and an attractive benefits package to full time employees which includes:
Oversee operational aspects of clinical trials including creation of operations plans with tracking and management of deliverables. Participate in clinical trials team meetings; understand project goals, identify tasks, and follow up progress to manage trials toward established goals and target dates. Manage contracts for external vendors (CROs) to implement clinical trials including, but not limited to, oversight of site monitoring plans, adverse event reporting monitoring plans, worksheet development, data handling and entry guidelines and data management plans, identification and tracking of key study metrics; anticipation/early identification of issues and root cause investigations with issue resolution and/or escalation as needed. Develop and track study budgets. Assist with developing and reviewing scientific documents including protocols, investigator brochures, and generic consent forms.
Complete work in accordance with the guidelines of internal SOPs and study-specific procedures pertaining to management of clinical studies according to GCPs. Select and manage sites conducting appropriate clinical trials including educating sites, assisting with IRB submissions, answering protocol- and patient-related questions, assisting with patient recruitment plans, monitoring site performance, assisting with maintenance of regulatory documents, and supporting sites during audits/inspections.
Bachelor’s degree in a scientific discipline; advanced degree (RN, MS) desirable but not required. Minimum of 2 years experience in clinical research operations and/or clinical project management (Phases 1 through 3) in CRO, pharmaceutical or biotechnology environment. Strong working knowledge of ICH GCP guidelines and FDA (CBER) requirements for clinical trials. Proficient computer skills to facilitate communications track and manage projects (proficiency in MS Word, Excel, Power Point, MS Project). Self-starter with excellent organizational, interpersonal and problem solving skills.
Assist in the development and management of clinical trial projects and support the Clinical Department with various functions. Responsibilities may include processing and maintenance of clinical study documents, providing overall operational support for project teams including meeting planning, organization, implementation and documentation, review of study plans, regulatory documents and monitoring reports, assistance with protocol and Investigator's Brochure development and maintenance of the electronic reference library. Will interact with project team vendors and CROs, as necessary. Various other clinical project management support tasks, as assigned.
Bachelor’s degree (applied science preferred) with at least one year experience in a CRO or a pharmaceutical/biotech company setting in either a clinical or regulatory department. Must be detail-oriented and an effective communicator with multi-disciplinary team members. Proficiency/experience in computer software including MS Outlook, Word, Excel, Project and Powerpoint.
Provide general administrative shared support to Senior Management in Clinical Research and Investor Relations. Schedule meetings, coordinate travel, handle correspondence, assist in the preparation of presentation materials for partnering and IR meetings and various other administrative functions and projects as assigned.
Minimum of two years of related experience in an office environment. Work experience in the pharmaceutical/biotech industry is desirable. Computer literate in Microsoft WORD, EXCEL, OUTLOOK and strong POWERPOINT skills. Self-starter with excellent organizational and interpersonal skills and the ability to multi-task.
Click for more information on the following items:
