Outset is a medical technology company pioneering a first-of-its-kind
technology to reduce the cost and complexity of dialysis. The Tablo
Hemodialysis System, FDA cleared for use from the hospital to the home,
represents a significant technological advancement that transforms the
dialysis experience for patients and operationally simplifies it for
providers. Tablo serves as a single enterprise solution that can be utilized
across the continuum of care, allowing dialysis to be delivered anytime,
anywhere and by anyone. The integration of water purification and on-demand
dialysate production enables Tablo to serve as a dialysis clinic on wheels,
with 2-way wireless data transmission and a proprietary data analytics
platform powering a new holistic approach to dialysis care.
**Position Overview **
The Clinical Project Manager (CPM) will be responsible for managing all
aspects of clinical operations for assigned studies, to ensure the highest
standards of clinical study execution. Responsibilities will include the
design, implementation, and monitoring of assigned studies, Contract Research
Organization (CRO) and vendor selection and oversight, adherence to study
contract, protocol, appropriate safety regulations and data integrity. This
role will ensure compliance to SOPs, lead meetings, maintain study timelines,
and provide study updates to internal cross-functional and management teams.
Has established a high degree of competency in clinical research. Has obtained
prior exposure to all aspects of a clinical study and functions at a
proficient level of independence with a significant degree of autonomy in
conducting clinical research.
Essential Job Functions
- Serves as primary contact and resource for assigned clinical studies / projects. Ensures studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs.
- Provides comprehensive support of all operational aspects of assigned clinical studies, including the review and approval of protocols and study-related documents (e.g., Regulatory Binder, Study Plans, Case Report Forms, Informed Consent Templates).
- Collaborates with cross-functional stakeholders from R&D, regulatory affairs, marketing, and with external investigators to develop clinical studies, objectives and study designs for clinical evidence generation.
- Works with research sites to facilitate the successful and timely conduct of clinical studies. Includes site selection, startup, support of enrollment, and study closure activities.
- Oversees the monitoring, implementation and corrective actions for study progress using available study management tools.
- Maintains up-to-date knowledge of published literature in relevant therapeutic areas including a broad awareness of dialysis issues.
- Provides input and review of the development of in-house operations SOPs, guidelines and systems.
- Demonstrates thorough knowledge of and can coach others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
- Fully supports the Quality Policy by building quality into all aspects of this roles work and by maintaining compliance to all quality requirements.
- Bachelor's level degree or licensed certified health care training or equivalent combination of education and experience.
- Minimum of 5 years of experience in conducting clinical studies.
- Minimum of 2 years of experience in project management and/or oversight of clinical studies.
Skills and Abilities
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Must be approachable, show respect for others, and work effectively with a diversity of personalities.
- Good organizational skills and ability to meet tight deadlines in an environment of competing priorities.
- Excellent communication skills (both written and verbal), with ability to build effective relationships with study center staff and colleagues.
- Must have excellent computer skills and is able to work in Microsoft Office.
- Ability to travel as needed, up to 30%. May include conferences, professional associations, and customer visits (e.g., site qualification, initiation, training, and/or monitoring).