Pendulum Therapeutics
Director of Clinical Studies
Hybrid - San Francisco, CA · Director
Sponsorship not specifiedDetected 54 days ago
GCPData AnalysisProject ManagementJiraClinical TrialsClinical ResearchBioinformaticsMolecular BiologyResearchCommunicationCritical ThinkingPublic SpeakingOrganizational SkillsGxP
About the role
- The candidate should be a self-starter with expert attention to detail and coordination skills.
Responsibilities
- Support customer studies to enable claims and new insights for product, marketing and revenue teams
- Coordinate and support several concurrent clinical research activities, including contributing to protocol design, day to day operations, and data collection & management.
- This will include single-site, multi-site and investigator-initiated trials with the aim of building scientific credibility and insights for Pendulum products.
- Act as a liaison between internal teams and outside clinical collaborators while overseeing protocol adherence and compliance, addressing any issues related to study products (product labeling, shipments, storage, etc), procedures, participant issues or adverse events, and manage external vendor relationships, as needed.
- Help assure compliance with all relevant regulatory agencies, implement and maintain periodic quality control procedures, and maintain regulatory documentation
- Coordinate internal activities and communications including clinical team meetings, manage action items, track research progress, budget and quality standards.
- Coordinate and support the internal and external review of clinical study protocols, amendments and related documents, informed consent forms, study operations manuals, monitoring plans, and other study essential documents.
- Support and track IRB submissions and approvals
- Support clinical site management including taking an active role in site selection, training, timely entry of data into the study database and management of CRA clinical site monitoring visits.
- Collaborate with in-house marketing and creative team on asset development related to clinical activities, including but not limited to conference collateral, presentations, white papers, case studies, blog posts, email communication, and website copy
Requirements
- Minimum of 3 years experience in clinical trial coordination/program/project management
- Minimum of 3 years experience in a clinical organization
- Knowledge and experience of ICH GCP standards
- Experience with Investigator Brochures as well as Investigational New Drug Applications
- Ability to understand and carefully follow regulatory guidelines, procedures and safety guidelines related to clinical trials research
- Ability to master new systems quickly and adapt to constantly changing needs
- Experience in establishing the infrastructure required to implement and execute efficient clinical studies
- Data oriented, with the ability to quickly learn new systems and applications.
- Experience working with project tracking software such as Asana, Jira, etc.
- Proficient scientific and clinical understanding of microbiome science or the willingness and ability to learn quickly
Nice to have
- Preferred experience with electronic data capture (EDC) or electronic survey tools, such as Qualtrics
Compensation
- Salary & Benefits
Benefits
- The candidate will oversee the design and management of clinical health surveys, customer studies and clinical trial planning, design, preparation, management, evaluation and documentation.
- Bachelor's Degree, preferably in biological science, nursing, dietetics, life sciences, or medical science
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