Manager, Clinical Operations
- Job Title
- Manager, Clinical Operations
- Job ID
- BOSTON, MA 02210
- Other Location
Are you seeking to make an immediate impact? Are you interested in working for a company that encourages diversity of thought? Are you hoping to work in a stimulating, fun and entrepreneurial work environment? Then Activ Surgical is the place for you!
Proudly headquartered in Boston, Activ Surgical (founded in 2017) completed the world's first autonomous robotic surgery of soft tissue. Activ Surgical is building hardware-agnostic surgical software that allows minimally invasive surgical systems to autonomously collaborate with surgeons. The first product augments surgical vision equipment in real-time in order to provide critical information to surgeons not currently available today.
Job Essential Skills
The Clinical Operations Manager, supports the CSMO in planning and coordinating activities in all aspects of clinical trial operations. This position requires appropriate interpretation of significant policies and procedures. It involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.
This is a role well suited to an ambitious professional, looking for the next step in their career.
As a Manager, Clinical Operations you will be responsible for: Direct management (i.e., training, growth, development, and performance management) of a cross-functional Clinical Operations team.
- Provide leadership in execution and management of clinical studies in accordance with project goals and objectives.
- Write IRB protocols.
- Responsible for all aspects of trial set up, budgeting, resource plans, objectives, reporting, etc. from trial concept through to trial completion and coordination across functional areas. ·
- Oversee study budget planning and management, and accountable for external spend related to study execution.
- Ensure development of accurate study budgets, contract development and execution, payment and tracking of study expenditure.
- Tracks progress of studies and address problems proactively as necessary.
- Develops and utilizes SOPs, systems, and appropriate project management tools for efficiency in clinical study execution.
- Ensures quality and compliance of trial conduct with applicable GCP/ICH guidelines, regulations, SOPs, and other global regulatory requirements.
- Participates in the planning of quality assurance activities and coordinates the resolution of audit findings.
- Participates in the evaluation, selection, and management of external vendors, including measuring key performance indicators, and proper guidance of performance for activities assigned to vendors for clinical studies.
- Participates and has input in the development of clinical study synopsis and protocol in conjunction with the clinical development plans
- Builds and manages clinical team
- Bachelor or Masters (in Science or Healthcare discipline)
- At least 6 years related experience in clinical study operations for medical devices, either in industry or with a CRO.
- Experience with robotics is a plus.
- A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
- Experience managing financials, resource management, and metrics reporting to leadership.
- Outstanding verbal, written, and overall interpersonal communications skills.
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.