At Pulvinar Neuro, we believe that everyone should live life to their fullest, so we create cutting edge technologies that enable people to take charge of their lives. Our team of innovators are constantly pushing the boundaries of what's possible. Are you ready to be part of a dynamic, innovative team with a shared purpose that truly matters? Looking for the thrill of a startup that is fully backed by an established medical device manufacturer?
Consider joining our team!
Consider joining our team!
Clinical Studies Manager
The role of the Clinical Studies Manager will work closely with senior leadership and cross-functionally with other team members to ensure that clinical programs are executed and delivered in accordance with the overall clinical development strategy and establish and manage against a set of metrics for quality, timeliness, and efficacy.
This position is based in Durham, NC.
What will you be doing?
- Oversee the design and implementation of operational excellence activities including program and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials
- Assist with the development of forecasting and management of functional/trial budgets
- Develop and execute staffing plans to ensure adequate and appropriate monitoring of all monitored trials
- Develop and implement clinical monitoring training program to include GCP, monitoring and site management skills, as well as protocol-specific training (in collaboration with Medical Monitor)
- Develop and maintain data storage system including trial master file setup and management, ensuring that data is correctly collected and stored, monitoring and recording any protocol deviations
- Identify outsourcing needs and oversee the selection, management, and performance of CROs, vendors and external consultants; sets standards for selection and evaluation of, and regularly reviews effectiveness of, CROs and vendors
- Contribute to clinical protocol design and development of critical study documents, such as protocols and related documents, clinical QA plans, Investigator Brochures, data management plans, Clinical Study Reports, regulatory submissions, etc.
- Apply knowledge of consenting of human subjects and data management requirements as per GCP
- Implement a strong quality culture ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies, and industry best practices
- Establish quality processes within Clinical Operations that focus on data integrity and patient safety
- Lead the development and optimization of processes for Clinical Operations (SOPs)
- Proactively assess the need for new/updated processes and implements process improvement initiatives
- Minimum 5 years' experience in clinical trials with record of increasing responsibility and exposure to a variety of roles
- A Bachelor's Degree in a relevant field preferably Biological/Life Sciences
- Strong working knowledge of GCP/ICH guidelines
- Extensive knowledge of clinical development preferably with medical devices or Phase I-III experience
- Be a team player who is "hands-on" in their work, leadership, management, and teaching style with a willingness to learn from a multifunctional team
- A strategic, agile, flexible thinker who is creative, and can work in a highly dynamic and innovative environment
- Proven ability to perform successfully under tight timelines and with changing and competing priorities
- Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge
- Have outstanding leadership and organizational skills and operational capabilities
- Ability to handle complex issues and multi-task current project demands; must be able to prioritize and deliver effectively and on-time with minimal supervision
- Have enthusiasm, scientific curiosity, high emotional intelligence, sound temperament and professional attitude
- Previous exposure to startups or entrepreneurial ventures is an advantage in our pursuit of cutting-edge innovation
To apply, please send your resume and cover letter to firstname.lastname@example.org . We look forward to hearing from you!
Pulvinar Neuro complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Pulvinar Neuro makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Pulvinar Neuro complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.