Clinical Project Manager
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POST DATE 9/17/2016
END DATE 10/18/2016
DaVinci Biosciences LLC
Yorba Linda, CA
JOB DESCRIPTIONDaVinci Biosciences is an innovative biological research company focused on the discovery and development of cell-based therapeutics and the production of human biological tools. We have two business units:
DaVinci Biosciences is dedicated to the responsible research and development of therapeutic products to improve the quality of life for individuals suffering from degenerative disease and injuries. We strive to innovate and lead in regenerative medicine, to initiate early phase clinical trials in therapeutic areas with medical need, and to be worldwide renown for our scientific achievements and our commitment to patient safety, health, and well-being.
DV Biologics provides researchers and biopharmaceutical companies with human biological tools and cell culture products that enable them to advance their investigative work and discover tomorrow s medical breakthroughs.
In addition to the opportunity of joining a dynamic research organization with global collaborations, DaVinci Biosciences offers its associates competitive salaries and benefits. DaVinci Biosciences offers medical, dental and life insurance; short and long term disability; and holiday/vacation time.
The Clinical Project Manager (CPM) will be responsible for coordinating and managing all aspects of clinical study activities while adhering to ICH/GCP, complying with the regulations/guidelines of the applicable Regulatory Authorities, and meeting project goals within the timelines and budget of a clinical development program. This position will help design and implement a clinical program from preclinical state to a clinical development program. The level of independence and scope of responsibilities assigned may vary depending on the experience of the successful candidate.
This position will work closely with cross-functional representatives from the R&D scientific staff, Regulatory/QC/QA, Operations, and others, to ensure successful completion of all clinical project deliverables. Clinical project deliverables include study design, organization of projects tasks, preparation of clinical and regulatory study documents, and selection and operational oversight of the study team, investigators, vendors/CROs all according to policies, standards, and guidelines in order to initiate and execute clinical studies within the required time frame and budget. The CPM will also provide oversight of other third party vendors on assigned study. This is an in-house position.
Overall responsibility for assigned early phase studies from study planning and design through execution in accordance with ICH/GCP and applicable regulatory authority
Write or contribute to the preparation of all documents related to the clinical study, its planning and regulatory submission, its execution, and required updates and reports: clinical study protocols, amendments, informed consent forms, investigator brochures, clinical research SOPs, case report forms, study guides, and reports in the appropriate formats
Aid in writing or reviewing ancillary documents required for submission and approval of clinical study; documents may include non-clinical study reports, investigational product specifications, and GMP production SOPs for the clinical investigational product
Develop working knowledge of the clinical investigational product and the disease indication in the assigned clinical studies
Develop and maintain strong knowledge of the clinical and regulatory landscape relevant to assigned clinical studies
Communicate regularly with team, investigators, and vendors to drive progress on study and address any issues; communicate regularly with manager to update and resolve any question
Data collection and role in data management
Monitoring the clinical study on site or remotely
Investigate queries and monitor discrepancies to ensure integrity of the data
Ensure compliance with study protocol and protection of human subjects
Work with scientific/medical team to ensure adherence to regulatory requirements
Aid in writing or contributing to interim reports and regulatory updates
Implement activities of assigned clinical study in accordance to Clinical and Regulatory policies, standards, and guideline
Availability for potential travel domestically and internationally