Clinical Operations Lead (Respiratory / Pulmonary) – NC Pharma/Remote
Our client, a NC based clinical stage Pharmaceutical company developing therapies to treat pulmonary disease, is actively recruiting for an exceedingly competent and knowledgeable Clinical Operations Lead to drive the day to day clinical operations for Respiratory trials. This is a small growing entity and a critical and impactful role within the organization. The company is open to home-based candidates on the East Coast.
The Clinical Operations Lead will be primarily responsible for overseeing 3rd party partners (CRO or academic), to include oversight of all aspects of clinical trial start-up and execution. The select candidate will be responsible for managing the clinical trial process from start-up to close-out.
Key Things to Note:
- The company is developing therapies in the Pulmonary space. Experience with Pulmonary or Respiratory trials is preferred.
- Phase II and III trials are underway and additional trials are planned.
- Role will involve hands-on oversight of clinical operations including day-to day management of the CRO and all trial-related tasks and timelines. Substantial experience as a monitor/CRA is required.
- The company employs CROs for most monitoring. Experience coordinating and overseeing the work done by CROs will be important.
- This company is still developing its operating policies and practices. We seek a candidate who enjoys a building environment and will bring the resourcefulness, initiative and can-do work style needed to be successful.
The Clinical Operations Lead will drive the process by providing expert operational oversight and guidance on multiple clinical studies.
Specific duties will include:
- Responsible for oversight of clinical operations and 3rd party partners across assigned clinical programs
- Responsible for collaborating with Site Managers in the directing, planning, organizing, supervising of CRO partner services across all sites, to include contracting, trial initiation and budgeting, site communication and coordination, patient recruiting, data monitoring and reporting, regulatory submissions, coordinating vendor and CRO partnerships
- Tracks and monitors that clinical operational goals are met, driving 3rd party partners in the process
- Ensures the highest safety and GCP standard
- Regular communication with CRO, vendors and individual sites
- Create, analyze and present data and reports to clinical leadership
- Develop and monitor program goals and objectives, including clinical monitoring visits, recruiting reports, and other key metrics of clinical trial success
Targeted candidate will offer a degree in a related field, plus 5+ years of clinical trial management and oversight in Pharma or Biotech – to include 2-4 years as a field CRA. Experience working on Pulmonary or Respiratory trials is preferred.
Other priorities include:
- Experience managing Phases II-III clinical trials, timelines and deliverables
- Experience overseeing vendors, including CROs
- Experience monitoring managing Pulmonary or Respiratory trials
- Excellent verbal and written communication
- Keen attention to details
- Longevity and growth in previous role
Finally, we seek a very sharp, knowledgeable and organized professional who will work exceedingly well in a dynamic and collaborative setting. One who can gain the respect and cooperation of all stakeholders in order to achieve shared success.
This is an immediate need. Please forward Word resume for prompt consideration.