HealthMode is seeking a motivated candidate who is passionate about supporting the growth of an innovative company committed to improving clinical trials by better measuring health. As Clinical Project Lead you will be the HealthMode project leader for a portfolio of studies onsite with one of our partner companies. You will be responsible for attending all project meetings and leading all study activities for a suite of clinical trials across multiple indications in a fast-moving development program. You will work closely with leadership several functional groups at both HealthMode and our partner organization to facilitate communication and decision making to complete projects on time and on budget. This role is based onsite in New Haven, CT.
HealthMode was created to improve clinical trials and healthcare through the development of digital patient measures. We develop products that collect patient data from real-world settings and transform them into quantifiable clinical measures providing evidence for clinical trials and patient care. We follow a 3-step product validation path, 1) product feasibility study, 2) data collection and model development, and 3) clinical validation. On this path, we develop industry and clinical research partnerships that support the development and adoption of the new measures. We integrate regulatory discussions throughout our process to speed up innovation adoption within the pharmaceutical industry.
You will be responsible for:
- Independently managing multiple studies within agreed upon budget, timelines, and in accordance with internal SOP’s and GCP/ICH guidelines
- Establishing study timelines and milestones; tracking and reporting study metrics
- Overseeing investigator selection, recruitment and support through the trial
- Developing and maintaining study budget tracking tools to ensure that trial costs are accurately tracked and reported
- Ensuring study staff is appropriately trained on relevant guidelines, regulations and SOPs.
- Participating in program strategy meetings, and ad hoc clinical operations initiatives and programs.
- Contributing to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, updates to regulatory authorities, and trial status updates.
- Ensuring Trial Master File is accurate and up to date.
- Tracking study progress to ensure timely data collection, monitoring, and data quality
- Working independently within a distributed team
- Being proactive, target driven and diligent
- Working for multiple stakeholders and managing multiple priorities
- Using your initiative to work both independently and as an effective team player
- Communicating with colleagues with diverse expertise in a multidisciplinary and multicultural environment
- Working with a wide and diverse network of groups and individuals across continents and time zones
- Leading collaborative projects
- Taking feedback and adapting to changing priorities
- An undergraduate degree in a relevant discipline
- 3+ years of experience managing clinical trials for pharma/biotech/CRO
- Documented training of knowledge current FDA Regulations and GCP
- Working knowledge and understanding of key regulatory authorities, ICH Guidelines and Good Clinical Practice (GCP).
- Proficient written and verbal communication skills
- Ability to collaborate effectively with cross functional team members and external partners
- A can-do attitude and excellent attention to detail