Clinical Study Manager
Job Title: Clinical Study Manager
Department: Clinical Operations
Location: Durham, NC
The Clinical Development Manager manages global clinical studies for one or more product candidates, with one or more indications, from early development to regulatory approval (Phase 1-3) and beyond, in order to achieve a high quality product for the marketplace and business success for company. This involves participation in all aspects of study design, execution, analysis and reporting, including critical document design (protocol, CRF, data management plan, statistical analysis plan, clinical study report), vendor selection and management, oversight of investigator selection, study conduct and site monitoring, data collection, analysis planning and reporting, managing clinical supplies, quality control, and study budget development and tracking to ensure compliance with regulatory and ICH/FDA GCP guidelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Contribute to the preparation for approval of Clinical Development Plans, budgets and proposed go/no-go decision criteria for one or more global development programs ensuring the needs and requirements of all regions are met
- Manage internal resources, external partners, consultants, vendors and external budgets to ensure the timely and cost-effective implementation of the Clinical Development Plan for one or more global development programs
- Supervise and mentor direct and indirect reports, as necessary
- Assess and recommend CROs and preferred vendors for implementation of clinical studies
- Review and approve contracts, work orders and invoices within grant of authority
- Coordinate and manage production of key deliverables for clinical trials, including protocols, case report forms, statistical analysis plans, data management plans and clinical study reports
- Represent Clinical Development in integrated product development clinical sub-teams to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide
- Establish and maintain effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders in order to meet program objectives and support achievement of department and corporate goals
Bachelorís degree in biological sciences, pharmacy nursing or related field preferred. A minimum of 5 years of pharmaceutical development experience in a Sponsor and/or CRO role and at least 3 years in a clinical study management role with a minimum of 1 year directly managing a Phase 2 or 3 clinical study. Hands-on experience with managing more than one major, multi-country, clinical program is desirable. Familiarity with clinical trial design and conduct, GCP, statistical analysis, data management, management of cross-functional clinical/ regulatory teams and CROs.
Distinguishing Characteristics of this Level
Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in clinical trial design, conduct and interpretation of scientific data.
Additional requirements include strong leadership and inter-personal skills and the ability to manage and cultivate relationships and foster employee development and the ability to recommend/make high-level decisions and to communicate effectively on a senior management level and externally.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.