The Clinical Affairs Manager will be responsible for driving the development of evidence to support the adoption of existing pharmaceutical portfolio products on a global basis. Additionally, the Clinical Affairs Manager will serve as an effective liaison to build relationships between the business unit and global key opinion leaders and professional societies. The Clinical Affairs Manager provides key energy, inputs, and support to upstream and business expansion projects and processes. The Clinical Affairs Manager should have a depth of experience in clinical trials management.
We are seeking clinical affairs managers who are career-driven, have strong leadership skills, and a depth of experience in driving successful clinical trial teams We offer accelerated career growth potential, and excellent benefits. We have many opportunities and consider only the best candidates to join our highly talented clinical affairs team.
typical roles and responsibilities for Clinical Affairs Manager
- Initiate, develop and maintain liaison among physicians/investigators, other applicable medical professionals including Contract Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/Registries from initiation through completion.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and reports and data presentation in publications.
- Manage selection of clinical sites and study protocol training
- Oversee clinical data collection, trial monitoring and auditing according to GCP guidelines and Standard Operating Procedures
- Prepare required documentation for regulatory agencies
- Represent the clinical trials management during clinical trial case review with physicians, hospital staff and coordinators
- Ensure all safety reporting of procedural and post-procedural adverse events
Requirements for the Clinical Affairs Manager
- A bachelor's degree in a scientific discipline; advanced degree preferred. Candidates with professional certification relevant to the study and with exceptional experience will be considered
- 5+ years clinical projects experience which should include at least 2 years managing a clinical research team.
- Broad cross-disciplinary knowledge of clinical research
- A depth of experience implementing new clinical projects
- Experience creating and managing budgets
- Advanced computer skills including spreadsheet, word processing, database management, power point and other necessary applications.
- Experience with CTMS systems
Salary range for Clinical Affairs Manager