Director of Clinical Studies

Create update and manage clinical health surveys oversee data integrity and coordinate and oversee data analysis efforts through dashboard development and reporting with the goal of achieving actionable insights marketing claims generation and exploratory signals to inform future clinical trials

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

Ensure all clinical trial activities remain in compliance with Good Clinical Practice (GCP)

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

Support a cross-functional team including the Revenue team Marketing Manufacturing Data and Research & Development

Bachelors Degree preferably in biological science nursing dietetics life sciences or medical science

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

Excellent organizational skills with attention to detail

Strong communication and critical thinking skills actively contributing ideas energy and desire to succeed as a team with a strong personal and professional drive to get things done

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. Preferred experience with electronic data capture (EDC) or electronic survey tools such as Qualtrics

Experience working with project tracking software such as Asana Jira etc.

Flexibility to think and work outside the box in the design conduct and implement clinical trials including the willingness to explore novel approaches to the conduct of studies

Proficient scientific and clinical understanding of microbiome science or the willingness and ability to learn quickly

Experience in implementing and prioritizing work across multiple projects under tight time constraints

Demonstrated ability to work independently and be a true Team Player who can work cross-functionally to achieve results in a fast paced environment