BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Clinical Project Manager/CTM to work for a leading San Diego biotechnology company.
Clinical Project Manager/CTM
The overall responsibility will be to co-manage a Phase 3 study for one of our Clinical programs. The successful candidate will manage CROs, clinical sites, liaise with Finance and Project Management and be responsible for assisting in the coordination of clinical study reports and clinical sections of the IB, IND/CTAs and NDAs/MAAs.
Primary Duties and Responsibilities
Acts as a primary liaison to CROs and vendors for one or more clinical studies, providing Company representation and adherence to project scope, deliverables and timetables.
Tracks and reports clinical information regarding patient recruitment and screening, monitors PK/PD data and coordinates other clinical study needs.
Interacts with active and potential clinical investigators.
Conducts study monitoring visits and co-monitoring visits with CRAOs as needed.
Organizes meetings and teleconferences for clinical and safety issues.
Works with CROs and/or clinical sites to complete informed consent documents, CRFs, protocols, SAE reports and other study documentation.
Organizes and runs meetings and teleconferences for clinical and safety issues for clinical studies.
Coordinates clinical project timelines with Project Management to meet critical milestones; and/or escalates issues that may jeopardize timelines and deliverables.
Liaises with other functional areas, such as Preclinical Development, Pharmaceutical Sciences and Regulatory Affairs in order to accurately coordinate clinical study activity.
Participates in the writing of clinical study reports and clinical sections of the Investigators Brochure, INDs/CTAs and NDAs/MAAs.
Coordinates with Finance to track the financial status against budget.
Maintains up-to-date knowledge of clinical principles and theories of drug development and study design in Company therapeutic areas (oncology, anti-virals, and inflammation).
Maintains clinical study files per ICH guidance.
May train CRAs to be hired in the future.
Writes clinical SOPs.
Other duties as may be necessary.
Bachelorâ€™s Degree with a science major preferred.
8+ years of clinical operations and overall drug development in the pharmaceutical/biotechnology industry.
At least 5+ years of intimate knowledge of the rheumatology, or a combination of inflammation, oncology and other therapeutic areas.
Strong experience in management of CROs.
Demonstrated skills in protocol, CRF and the development of study documentation.
Knowledge of FDA regulations and ICH guidelines regarding GCPs.
Phase 1-3 clinical trial experience; Phase 3 global experience required.
Demonstrated experience in writing the clinical sections of an IB, IND and/or NDA.
Proficiency in strategizing, planning, monitoring and problem solving.
Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly.
Ability to manage multiple and diverse issues.
Strong facilitation, organizational, analytical and time management skills.
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project.
Ability to apply knowledge to new situations.
Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement.
Ability to â€œroll up your sleevesâ€ and individually contribute results to a research and development effort.
Experience writing technical and management documents, reports and presentations.
Ability to travel up to 25%.
BioPhase Solutions - 11 months ago