Clinical Data Management (Contract to Hire)

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

The Clinical Data Manager (CDM) reports directly to the Director, Data Management and is responsible for supporting a wide variety of data management activities across all clinical research programs and studies.   This role will support database design/development, medical coding, data systems and quality, and vendor oversight.  The CDM will provide operational excellence in partnership with Clinical Operations, Science and Technology teams, Biostatistics, R&D Strategy and other functional areas throughout the company.

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 can be remote and will report into the Clinical Operations team located in our trendy TriBeCa HQ.  This position is a 6 month contract to hire opportunity.

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