Clinical Trial Manager

Who We Are:

Click Therapeutics, Inc. develops, validates and commercializes software as prescription medical treatments for patients 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 has entered a pivotal, fully remote, randomized, controlled trial on the Verily platform for the treatment of Major Depressive Disorder (MDD) in up to 540 adults. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including MDD, Schizophrenia, Migraine, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome (ACS), Obesity and more.

About the Role:

The Clinical Trial Manager (CTM), reports directly to the Director, Clinical Operations and is responsible for the planning and execution of traditional and decentralized clinical trials.. This includes, but is not limited to: Randomized Controlled Trials, pilot studies, long term follow-up studies, and HEOR clinical research studies. This 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, clients and sites and serve as the primary point of contact. 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.

Generally positions at Click can be on-site, remote or hybrid (an optimal combination of remote and on-site). Our headquarters is located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities. We also have dedicated spaces in central Miami, San Francisco, and Boston, and, in addition, via our partnership with Industrious, any Click employee can access co-working locations nationally.

The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. 

Responsibilities:

• Design and execute a variety of clinical study designs
• Assumes overall responsibility for development of protocols, recruitment strategies and mitigation activities to increase patient randomization, monitoring plans and data management oversight; IRB/Ethics committee approval and management of vendors and study site the trial contracts
• Participates in protocol, CRF and strategy development, Clinical Study Report preparation, IDE submission and publications, as appropriate
• Collaborates cross-functionally with Science, Medical Affairs, and Product teams
• Prepares metrics and updates for management
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Participates in and facilitates CRO/vendor selection process for outsourced activities
• Identifies and coordinates study specific training for clinical staff and cross functional personnel for protocol execution, CRF completion, adverse event reporting and pharmacovigilance.
• Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Recommends and implements innovative process ideas and novel recruitment strategies to impact clinical trials management
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
• Has responsibility for the financial management of the clinical trial in conjunction with the finance department
• Establishes procedures to ensure adherence to trial protocols, administrative requirements, timeline milestones
• Acts as the point of contact for all external and cross functional teams
• Provides regular and ad hoc information, both written and verbal, internal/external teams to include reports, updates, guidance, preformed commitments and, possibly, a site newsletter

Qualifications:

• Bachelor's Degree required/ Advanced Degree preferred in life sciences, health care or related discipline
• Trial Manager experience 2+ years in biotech, pharma, or CRO setting is a minimum requirement
• Experience with commercial IRBs (e.g. WIRB, Advarra)
• Working knowledge of Good Clinical Practice (GCP) and US and international regulations for 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 20%, 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

Benefits:

Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more…

Equal Employment Opportunity:

Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.