Clinical Trial Leader
South San Francisco, CA | Contract
Bayside Solutions is seeking a Clinical Trial Leader to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Trial Leader
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, drug supply and biomarker / sample management plans, TMF, and CSRs.
- Draft and implement study plans including; vendor oversight, risk, quality, safety, communication, trial/medical monitoring, TMF.
- Ensure TMF creation and QC completion.
- Support EDC and CTMS systems and data maintenance.
- Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
- Provide input to the study budget and manage assigned vendor budgets
- Participate in selection of vendors (participates in the Request for Proposal (RFP) process), on a global scale, in collaboration with the PETL.
- Utilize outputs from operational analytical tools to enhance and improve study execution.
- Oversee delegated outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
- Assist with all activities related to global site selection, contracting, set-up and maintenance.
- Proactively identify risks and develops risk mitigation strategies to ensure operational effectiveness.
- Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems.
- Ensure study adherence to ICH/GCP and SOPs.
- Bachelor’ s degree or equivalent required (scientific or healthcare discipline preferred).
- 5+ years of study management experience in clinical and drug development.
- Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
- Experienced in managing aspects of one or more early development phase (I and II), global, complex, clinical studies and generally experienced in clinical research/development.
- Highly effective verbal (including oral presentations) and written communication skills in English; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders.
- Experience with effective vendor management.
- Demonstrates an aptitude for strategic thinking skills; manages risks (including risk identification and mitigation); identifies critical path / critical dependencies.
- Strong customer focus with investigators, functional peers, vendors, country affiliates, etc.