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Clinical Data Management Jobs
Company | Click Therapeutics, Inc. |
Address | New York, NY, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-08-08 |
Posted at | 10 months ago |
Who We Are
- Prepares and distributes project status reports to project team and management
- 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
- 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
- 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
- Contributes in the development, review, and implementation of departmental SOPs, Work Instructions, templates, guidelines, etc.
- Prepares and reports query trends and data/query/CRF completion/missing pages/SDV metrics to the Study Management Team (SMT)
- 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
- 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
- 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
- Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications
- 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
- Presents information in a concise, user-friendly format by determining target audience needs to support decision processes outcomes
- Contributes to protocol design, study build, validation, clinical databases and data validation activities
- Designs, modifies and manages study eSource documents
- Ensures data management activities are conducted in accordance with ICH/GCP, internal SOPs and Work Instructions, and meet all regulatory requirements
- Understanding of clinical data, efficiencies in managing its collection, oversight of its management and assurance of its integrity in the clinical trial process
- Provides training to internal or external team members, as needed
- Oversee data cleaning activities and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
- Generates routine and ad-hoc reports using internal and external data sources
- 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
- Organized and detail-oriented
- Clinical Data Management 3+ years’ experience across Phase 1-4 clinical trials
- EDC experience in multiple systems
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
- Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology
- Bachelor's Degree or Master’s Degree in math, science, health-related field or equivalent experience
- Ability to deliver results and execute required activities individually and in a team setting
- Click Therapeutics will conduct interviews face-to-face over Zoom.
- All job postings will be listed on the Click Therapeutics official career page. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below.
- Click Therapeutics will only reach out to you through an “@clicktherapeutics.com” email address.
- Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver’s License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams).
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