Job: Clinical Project Manager (Immunotherapy /Oncology /Cell Therapy) – RTP, NC, Frankel Staffing Partners, RTP, NC
Our client, an RTP-area biopharmaceutical company that is developing immunotherapies to fight cancer and other diseases, is actively recruiting for an exceedingly competent and knowledgeable Project Manager to drive the clinical development plans and deliverables for its clinical studies. This is a critical and impactful role within the organization and company will pay industry-leading wage to retain and attract a star.
This company is building. It has multiple products in development and is aggressively pursuing targets for its proprietary technology. The future is very bright and this CPM will lead the study strategy and planning, overseeing multiple clinical studies, to include driving cross functional teams and CROs / vendors.
Key Things to Note:
? The company is developing immunotherapies to treat various cancers, as well as infectious diseases (including COVID) and other ailments.
? Phase I and II trials are underway and additional trials are planned.
? This Clinical Project Manager will be responsible for overseeing and guiding multiple clinical studies (phases I-III), overseeing outsourced partners, as well as review and monitoring of work performed, metrics, compliance, risk and mitigation strategies. Seek candidate from biotech or pharma who is accustomed to driving these functions.
? The company employs CROs for most monitoring. Experience coordinating and overseeing the work done by CROs will be important.
? This role is based in the RTP, NC area and will be split between home and office-based. Seek RTP, NC area candidates only.
? This company is still developing its operating policies and practices. Seek candidate who enjoys a building environment and one who will bring the resourcefulness, initiative and can-do work style needed to be successful.
This Clinical PM drives the clinical development plan and deliverables by providing expert operational oversight and guidance on multiple clinical studies.
Specific duties will include:
? Oversee and manage daily clinical operations, including management of timelines, budgets, deliverables, vendors and onsite clinical staff
? Track and prepare study data utilizing clinical trial management systems, databases, spreadsheets, and other tools
? Accountable for meeting clinical trial objectives, milestones, and deliverables, as well as reporting trial progress to management
? Contributes, maintains and manages internal TMF and study documents, to include protocol, amendments, ICFs, CRFs, CSRs, IND, annual reports, PSUR, IB and NDA
? Assists in the identification, qualification, and management of third-party vendors, to include development of Request for Proposals (RFPs), Scope of Work (SOW), and vendor specifications documents
? Oversees investigators, to include participating in investigator meetings, approving investigator payments and following up as needed
Targeted candidate will offer a scientific degree (advanced degrees welcome) and 5+ years of clinical research experience in Pharma or Biotech. Experience working on Oncology, Immunology or Cell Therapy trials is needed. Background working directly for the sponsor (Pharma / Biotech) is also important.
Other priorities include:
? Experience managing Phases I-III clinical trials, timelines and deliverables
? Experience overseeing vendors, including CROs
? Experience monitoring managing Oncology, immunotherapy of cell-therapy trials is required
? 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. Local candidates only.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.