Clinical Data Management

Who We Are

Click Therapeutics, Inc. develops 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 360 adults. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including MDD, Schizophrenia, Migraine, MS, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome (ACS), Obesity, Oncology and more.

About the Role

As Manager, Business Development & Alliance Management, you will have an exciting opportunity to drive the execution of Click’s partnership strategy. Together with our partners, you will establish and execute on a vision that maximizes the potential of our partnerships, and in doing so, will seek to address the unmet needs of patients worldwide. The Manager will develop end-to-end implementation plans and collaborate with functional area leaders internally and externally to progress collaboration programs and initiatives, while monitoring performance of the partnership and ensuring all of our obligations are met in a consistent, high quality, professional and timely manner. This will require strategic relationship management, effective program management, creative problem solving, and thorough diligence. The Manager will also seek opportunities to expand the scope and depth of partnerships in a manner that aligns with Click’s company strategy and goals. If you have an entrepreneurial spirit, are success-orientated, and you can work independently, you may be the right candidate to join our team. 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 an excellent wealth-building/equity opportunity for the right individual.

This position can either be based out of Click’s headquarters located in New York, NY or Boston, MA or Miami, FL or Remote.

Responsibilities

• Understanding of clinical data, efficiencies in managing its collection, oversight of its management and assurance of its integrity in the clinical trial process
• Contribute to the oversight of external service providers, the development, implementation and maintenance of appropriately validated systems/applications for clinical data management, and for providing data management support for clinical trials
• Contributes to protocol design, study build, validation, clinical databases and data validation activities
• Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications
• Designs, modifies and manages study eSource documents
• Generates routine and ad-hoc reports using internal and external data sources
• Prepares and distributes project status reports to project team and management
• Contributes in the development, review, and implementation of departmental SOPs, Work Instructions, templates, guidelines, etc.
• Ensures data management activities are conducted in accordance with ICH/GCP, internal SOPs and Work Instructions, and meet all regulatory requirements
• Participate in cross-functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback
• Provides training to internal or external team members, as needed
• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable
• Performs coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding with the clinical study manager and Medical Monitor
• Participates in the selection of suitable vendors for the outsourcing of DM activities, and for building effective DM vendor relationships. This includes being involved in request for proposals, contract negotiations (budgets, task orders and timelines) and selection of DM and/or technology, as needed​
• Supports clinical Data Management deliverables generated by external vendors (e.g., CROs) for outsourced study activities such as CRF design, database set-up activities, database specifications, data validation process, User Acceptance Testing, training of study site personnel in CRF completion, and data clarification processes
• Oversee data cleaning activities and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
• Prepares and reports query trends and data/query/CRF completion/missing pages/SDV metrics to the Study Management Team (SMT)
• Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission
• Presents information in a concise, user-friendly format by determining target audience needs to support decision processes outcomes

Qualifications

• Bachelor's Degree or Master’s Degree in math, science, health-related field or equivalent experience
• Clinical Data Management 3+ years’ experience across Phase 1-4 clinical trials
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology
• Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
• EDC experience in multiple systems
• Ability to deliver results and execute required activities individually and in a team setting
• Organized and detail-oriented
• Strong written and verbal communication skills in a compact clinical team working with aggressive timelines
• Highly responsive and proactive team player with a desire bring leadership skills into a rapidly growing company

Benefits

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. 

Stock options | Competitive Salary with Annual Review | 5% 401(k) matching | Annual Performance-Based Cash Bonus | Comprehensive Medical Benefits | Dental | Vision | Voluntary Benefits | Unlimited Vacation Time | Uber One | Nectar Rewards | One Medical | Fertility Support | Gym Pass | Citi Bike | Professional Development Stipend | Industrious Workspaces | Generous Paid Parental Leave | Commuter Subsidies | Monthly Lunch Stipend | Weekly Catered Lunches | Choice of Mac or Windows | 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.