Clinical Project Manager (Oncology/Remote) – NC BioPharma/Direct Hire
Our client, a NC-based Biopharmaceutical company that is developing treatments for oncology and other life-altering diseases, is actively recruiting for an exceedingly competent and knowledgeable Clinical Project Manager to lead global clinical studies and drive cross-functional teams and CROs / vendors.
This position can be remote, located anywhere in the US. This is a critical role and company will offer generous salary to attract and retain a star.
Key Things to Note:
- This is an established NC-based BioPharma with a growing and impressive oncology pipeline. Experience in Phase II and III oncology trials will be important.
- This Clinical Project Manager will be responsible for overseeing and guiding multiple clinical studies, overseeing outsourced partners, as well as reviewing and monitoring of work performed, metrics, compliance, risk and mitigation strategies. Seek a candidate from biotech or pharma who is accustomed to driving these functions.
- The company partners with multiple CROs, both global and domestic. Experience coordinating and overseeing the work done by global CROs will be important.
- This is a highly collaborative role involving regular interaction with cross-functional team members, clients and vendor partners. Right candidate will complement broad and deep knowledge of clinical operations with strong communication and interpersonal skills.
This Clinical PM will drive the clinical development plan and deliverables by providing expert operational oversight and guidance on multiple clinical studies.
Specific duties will include:
- Serve as the Study Lead for global Phase II or III clinical studies.
- Develop, write, and/or coordinate generation of clinical study documents including but not limited to clinical trial protocols, Investigator Brochures, clinical sections of regulatory submissions, and clinical study reports.
- Provide scientific expertise and leadership on assigned compounds to investigators, collaborators, vendors, and other key personnel.
- Coordinate and oversee activities of external vendors providing services for clinical studies, this could include vendor identification, RFP preparation, bid reviews and negotiations
- Maintain in-house clinical files for ongoing clinical studies, to include overseeing the collection, review, maintenance, and tracking of regulatory documents for clinical study centers.
- Define the monitoring plan for CROs, to include co-monitoring clinical sites as necessary and tracking and reviewing monitoring reports for accuracy and timely submission
- Collect, track, and summarize subject/patient information.
- Track study timelines to insure study is on track;
Targeted candidate will offer a scientific degree and 5+ years of clinical research experience in Pharma or Biotech. Experience working in Oncology trials is required. Working directly for the sponsor (Pharma / Biotech) is also important.
Other priorities include:
- Experience managing Phases II-III clinical trials, timelines and deliverables
- Experience overseeing vendors, including CROs
- Excellent verbal and written communication
- Keen attention to details
- Longevity and growth in previous roles
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.