The Sr. Clinical Data Manager leads and oversees the collection, processing, quality control, and delivery of clinical trial data. This role is responsible for managing timelines, data quality, and data integrity across assigned studies, ensuring compliance with GCP, GCDMP, SOPs, Health Authority and regulatory requirements.

The Sr. CDM collaborates closely with operational teams and external partners, coordinates clinical and laboratory database activities, aids in the definition of data requirements, study database development, and associated data processing documentation. The position also supports clinical development and internal projects, manages scientific and data-related queries, and operates independently within established Tyra Biosciences procedures and practices.

Key Job Responsibilities:

• Serve as Lead Data Manager, responsible for assigned clinical studies, ensuring high-quality, compliant and inspection-ready data deliverables.
• Provide hands-on oversight of study timelines, milestones, and deliverables; proactively communicate risks, status, and mitigation plans to departmental leadership and stakeholders.
• Accountable for the creation and execution of Data Transfer Specifications, QC of datasets and proper filing into data repository environment.
• Draft, manage and maintain study specific Data Management Plan.
• Work with project sponsors, stakeholders, and cross-functional team members to define project requirements, scope, risks, organization and approach.
• Ensure medical coding dictionaries are up to date, coding is contemporarily current and manage synonym lists in collaboration with cross functional teams.
• Lead CRF development to ensure alignment with protocol objectives, regulatory standards, and data collection best practices.
• Responsible for the design and development of study-specific databases, including edit check specifications, enhancements and post production changes.
• Perform User Acceptance Testing (UAT).
• Accountable for data review, cleaning, and quality control to ensure high quality analysis ready data delivery.
• Generate and analyze data review and QC reports to identify trends, risks, and corrective actions.
• Manage issue identification, escalation, and resolution to minimize study impact and maintain timelines.
• Maintain comprehensive documentation of data management activities in accordance with GCDMP and regulatory requirements.
• Lead study closeout activities, ensuring database lock readiness, documentation completeness, and proper archival.
• Other tasks as assigned by management.

Education & Experience Required

• A 4-year degree (BA/BS) from a recognized university in Life Sciences, Library Sciences or Computer Science, or Mathematics.
• 5+ years of experience as a CDM in Pharmaceutical or CRO setting
• Working familiarity of MEDDRA and WHODRUG
• Proficiency in the development and use of commercial EDC products and other common trial management systems (preference given for Medidata Rave)
• Experience using SAS/R and relational databases (e.g. MS SQL Server, MS Access, or Oracle)
• Experience in Early Development studies
• Experience or familiarity with healthy subject Clinical Pharmacology studies.
• Proficiency in use of Microsoft Suite products for the purpose of gathering and providing information to cross-functional team members
• Manage and maintain the Data Management (e)TMF, contributing to the Trial (e)TMF
• Demonstrated ability to work independently and in a team environment
• Applied knowledge of FDA, EMA, Health Canada and other significant Health Authority regulations
• Applied knowledge of CDISC and CDASH guidance standards.
• Excellent interpersonal skills
• Excellent project management and organizational skills in clinical trials setting
• Excellent communication and presentation skills, both documented and verbal

Pay Range and Benefits

Base Salary Range: $162,104 - $174,800 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Job Type: Full-Time

Work authorization: United States (Required)

Work Location: Remote

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.