Job Title: Director/Sr. Director of Clinical Operations 
Location: Remote  - East Coast 
Type: Direct Hire

Medical Device Company is hiring a Senior Director/Director of Clinical Operations to join their team! 

Requirements: 

• Bachelors Degree required, scientific/healthcare discipline preferred 
• 7+ years of clinical trial research and project management experience, medical device experience a plus 
• Experience managing CROs and vendors; contract/budgets and project timelines 
• Clinical trial management experience from study start-up through close out
• Thorough knowledge of FDA, ICH and GCP guidelines 
• Strong communication skills, written and oral 
• Ability to work independently, able to make decisions
• Strong interpersonal skills to interact with investigators, vendors, CRO, field and in-house individuals at all levels of the organization.
• People management experience a plus 
• Able to work in a small team environment 

• Responsible for all operational aspects for the development and implementation of clinical research projects 
• Assist Clinical team execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines.
• Develop and maintain clinical timelines using Microsoft Project; Manage and maintain the Project team tracker. Prepare and maintain project organograms. 
• Assist with the development and maintenance of the project and risk management plans.
• Manage the overall study budget, track invoices and facilitate clinical study and vendor (CRO and CRA) payments.
• Assist with execution of clinical studies including the management, of vendors including CROs, review of work orders and review of invoices. Interface with Clinical Affairs staff to ensure engagement and coordination of activities for clinical studies.
• Proactively identify areas of risk and contribute to the risk management plan. 
• Review study-related plans generated by CROs and vendors to ensure documentation is in accordance with GCP regulatory requirements and consistent with the protocol.
• Support the Clinical team with start-up activities including but not limited to investigational site contracts, investigational site and ethics committee/IRB submissions (working collaboratively with clinical site managers and external resources such as legal counsel).
• Provide support to the VP of Regulatory Affairs for regulatory submissions, filings and strategy, including regulatory reporting of safety events to appropriate regulatory authorities. 
• Support the preparation of Clinical related information for Board of Directors and other stakeholders under the direction of the Director of Clinical Compliance.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.