Who We Are
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Major pipeline expansion and progression is in process.
About the Role
The Clinical Trial Manager (CTM) reports directly to the Head of Clinical Operations and is responsible for the planning and execution of one or more Phase 1-4 clinical research studies. This in-house position will provide operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP and applicable SOPs. This role will be responsible for managing all operational aspects for implementation of clinical trial activities from study start-up through database lock. The CTM will manage study-related service providers and serve as the primary point of contact for CROs and other service providers. The CTM should have strong critical thinking skills for problem solving and have strategic thinking capacity to drive study decisions that affect study outcomes and timelines.
This is a highly visible, creative, and agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. The role will be located in our trendy Tribeca HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.
- Assumes overall responsibility for the preparation of protocols and Informed Consent forms, finalization of monitoring and data management options (either in-house or contracted to a Contract Research Organization), Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, and management of the trial contracts with CROs, vendors and study sites.
- In conjunction with internal management, works with CROs to establish processes and mitigation strategies for outsourced clinical trials.
- Identifies and coordinates study specific training with the CROs Project Manager and other clinical staff for team communication, computer software and IT training, protocol and CRF, adverse event reporting and the importance of pharmacovigilance.
- Has responsibility for the financial management of the clinical trial study in conjunction with Head of Clinical Operations and the finance department.
- Establishes procedures to ensure adherence to trial protocols and administrative requirements.
- Efficiently maintains and manages the tracking of timeline milestones for all studies as well as overall day-to-day operations of clinical studies.
- Develops systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
- Ensures that all aspects of ICH/GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
- Acts as the point of contact for all external and internal functional teams.
- Provides regular and ad hoc information, both written and verbal, to all the trial participants, internal/external teams to include reports, updates, guidance, preformed commitments and, possibly, a site newsletter.
- If required and when applicable, co-monitors or performs CRA activities. These responsibilities are inclusive of but not limited to the following:
- Ensures study centers have adequate facilities, resources and training of site staff to trial-specific industry standards.
- Verifies that the investigator follows the approved protocol and all ICH/GCP procedures; source data/documents and other trial records are accurate, complete, and maintained through review of monitoring reports or co-monitoring visits.
- Adverse events, concomitant medications, and illnesses are reported in accordance with the protocol; data entered on to the CRFs is consistent with patient clinical notes.
- Communicates deviations from the protocol, SOPs, ICH/GCP, and the applicable regulatory requirements to internal management and the investigator as applicable.
- Manages and coordinates internal/external team meetings and internal/external investigator meetings.
- Bachelor's Degree required/ Advanced Degree preferred in life sciences, health care, or related discipline
- Clinical Research 4+ years’ experience, biotech, pharma, or CRO setting
- Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
- Experience with both early and late phase clinical trials
- Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology
- Ability to deliver results and execute on required activities individually, in a team setting
- Organized and detail-oriented
- Strong negotiating skills in a compact clinical team working with aggressive timelines
- Ability to travel up to 25%, generally within the US
- Highly responsive and proactive, a team player
- Initiative, enthusiasm and a problem-solving approach to new challenges.
- Systematic and efficient coordination skills, including an ability to prioritize