- Responsible for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial
- Lead cross-functional study execution team (SET) in support of study deliverables
- Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
- Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
- Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
- Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files
- Participates in service provider selection process as a part of outsourcing activities
- Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required
- Supports assessing operational feasibility, recommending study execution plan and site selection under the Sr. CTM or AD/Director of Clincal Operations
- Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
- Manage clinical trial budgets, providing ongoing financial reporting and projections
- Negotiate and finalize site contracts and budgets
- Perform and manage data review process on an ongoing basis
- Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed
- Oversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues
- Ensures tracking and review of protocol deviations and assesses impact on study data
- Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget
- Provides oversight for forecasting of clinical supplies, including study drug and supplies
- May manage and/or oversee work of junior Clinical Operations staff
- May support development and review of Clinical SOPs and other department initiatives
- Travel as needed to sites, conferences, industry meetings
- Other duties as may be assigned
- Bachelor's Degree
- 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
- Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills
- Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners
- Proven clinical operational skills to direct protocol execution to ensure timeline, budget and quality metrics are met
- Excellent communication skills to effectively disseminate information to project team and outside parties
- Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
- Clinical research knowledge and cross-functional understanding of clinical trial methodology
- Excellent organizational, conflict resolution, prioritization, and negotiation skills
- Proven ability in creative problem-solving and exercising sound judgment
- Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
- Ability to handle a high volume of highly complex tasks within a given timeline
- Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
- Working knowledge of MS Project for development and update of clinical study timelines
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Sr. Clinical Trail Manager - Emeryville, United States - BioSpace
Description
Job DetailsAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL SUMMARY:
4DMT is recruiting for a motivated and experienced Sr. Clinical Trial Manager to support the Company's clinical trial activities. This position reports to the Associate Director/ Director of Clinical Operations. This role will be within the ophthalmology program and will be responsible for management of the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities.
RESPONSIBILITIES:
Education:
(non-technical and technical skills)
