FierceBiotech and FiercePharma Jobs
Clinical Project Leader - DOR BioPharma, Inc.
Nov 26
Location: Ewing, NJCategories: Clinical
Website: http://www.dorbiopharma.com
Position Description
POSITION SUMMARY:
Under the direct supervision of and with assistance from the Director, Regulatory & Clinical Operations as well as assistance from the Chief Medical Officer, the Clinical Project Leader is accountable for the day-to-day operations of one or more clinical trials commensurate with complexity, including trial start-up, conduct, monitoring and close-out activities. This position will develop and implement initiatives aimed to ensure the successful and timely completion of the Phase 1, 2 and 3 clinical studies and all of the related clinical milestones. The lead product/program being evaluated in a confirmatory Phase 3 clinical trial, is orBec® (oral beclomethasone dipropionate), which represents a promising new treatment for GI GVHD (gastrointestinal graft-versus-host disease).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• For each assigned clinical study, provide input on clinical study design and operational plan, monitor trial progress, manage the project level budget, oversee quality assurance, manage external vendors (including, but not limited to data management), and ensure that all reporting activities are completed correctly and in a timely fashion.
• Direct site communication and clinical monitoring input related to product development.
• Oversee vendor training for all clinical aspects of drug development.
• Coordinate materials for clinical studies.
• Validate site-specific regulatory documents for IND/CTA and NDA/MAA filing – as well as for other countries’ regulatory bodies as needed.
• Track tasks performed by CRAs and independent contractors (including CROs).
• Monitor vendor GCP audits.
• Review and edit clinical documents and ensure that queries on study results and interpretations occur in a timely fashion.
• The CPM will have responsibility for reviewing, and creating Clinical Monitoring SOPs, managing training and providing a leadership role in the maintenance of Clinical Operations Monitoring standards.
ADDITIONAL DUTIES:
As assigned.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
• Master’s degree in a health-related field, or R.N. degree required.
• MSN or PhD with a focus in oncology and/or transplantation preferred.
EXPERIENCE:
• Participation in the successful management of Phase 3 registration study(ies) essential.
• Participation in the successful management of oncology and/or bone marrow transplantation study(ies) a plus.
• Broad experience with all aspects of clinical monitoring and oversight of contracted resources.
• The CPL candidate will have at least 2 years experience leading trials and at least 5 years of clinical research experience in the biotech, pharmaceutical, or contract research organization arena—of which at least 3 years experience must have been as a Clinical Research Associate (CRA) /Clinical Research Scientist (CRS).
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
Up to 25% travel time – as needed.
OTHER SKILLS AND ABILITIES:
• Fundamental knowledge of GCP, US IND and ICH regulations.
• Demonstrated experience in simultaneously managing multiple projects with aggressive timelines.
