Qureos Mentor

Kriya Therapeutics

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.<br>
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We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.<br>
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We are proud to have been named <b>Triangle Business Journal&rsquo;s Life Sciences 2024 &ldquo;Best Private Company to Work For,&rdquo;</b> recognized by Forbes as one of <b>&ldquo;America&rsquo;s Best Startup Employers of 2024,&rdquo; and honored as one of BioSpace&rsquo;s &ldquo;2025 Best Places to Work.&rdquo;</b></div><br>
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Role Overview</b></h3><div><br>
The Associate Director, Clinical Data Management Lead will be responsible for the strategic and operational execution of clinical data management activities across Kriya Therapeutics' clinical development programs. This role combines hands-on data management expertise with the orchestration of cross-functional coordination, ensuring data quality, integrity, and regulatory compliance throughout the product development lifecycle. The Associate Director will work closely with CROs, biostatistics, clinical operations, and regulatory teams to deliver high-quality clinical data that supports program advancement and regulatory submissions.<br>
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<b>Key Responsibilities</b>
</div><ul> <li>Lead and execute day-to-day clinical data management activities for assigned clinical studies, including database design, edit check development, data review, and database lock.</li>
<li>Shape and maintain study-specific data management plans, CRF completion guidelines, data validation specifications, and data transfer agreements.</li>
<li>Oversee CRO data management activities, ensuring deliverables meet quality standards, timelines, and contractual obligations.</li>
<li>Serve as the primary data management point of contact for cross-functional study teams, facilitating communication between clinical operations, biostatistics, medical monitoring, and regulatory affairs.</li>
<li>Ensure compliance with FDA, ICH-GCP, and other applicable regulatory requirements across all data management activities.</li>
<li>Develop and approve CRF designs, database structures, edit checks, and coding dictionaries (MedDRA, WHODrug) in collaboration with CRO partners.</li>
<li> Lead data reconciliation activities including SAE reconciliation, central lab data integration, and third-party vendor data transfers.</li>
<li> Support preparation for regulatory submissions by ensuring data packages meet quality standards and timelines, including CDISC (CDASH, SDTM) compliance.</li>
<li>Develop and maintain SOPs, work instructions, and best practices for clinical data management.</li>
<li>Plan audit and inspection readiness activities related to clinical data management, including TMF documentation.</li>
<li> Identify and drive process improvement opportunities and implement solutions to enhance data management efficiency and quality.</li>
<li>Provide data management input into study protocols, statistical analysis plans, and clinical study reports.</li></ul><br>
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Experience &amp; Skills and Work Environment<br>
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<div><b>Experience &amp; Skills</b></div><ul>
<li>Bachelor's degree in life sciences, health informatics, computer science, or a related field.</li>
<li>Minimum 12 years of clinical data management experience in pharmaceutical/biotech industry</li>
<li>Advanced degree preferred; or equivalent professional experience</li>
<li>Deep expertise managing data for Phase I-III clinical trials across multiple therapeutic areas Strong knowledge of GCP, 21 CFR Part 11, and global regulatory requirements</li>
<li>Extensive experience in regulatory filings (e.g., IND, CTA, NDA, BLA) and global clinical trials highly desired</li>
<li>Experience in the management/oversight of CROs performing monitoring activities is required</li>
<li>Strong understanding of drug development and program management from pre-IND through regulatory filing</li>
<li>Strong understanding of clinical trial protocols and data flow processes.</li>
<li>Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.</li>
<li>Excellent written and verbal communication skills are required.</li>
</ul><div><b>Work Environment</b></div><ul>
<li>Primarily desk-based, generally in an office or home office setting.</li>
<li>May involve extended periods of sitting and computer use.</li>
<li>Ability to stand for extended hours.</li>
<li>Ability to climb ladders/steps.</li></ul><br>
<h3 class="jobSectionHeader"><b>
Life at Kriya</b></h3><div><br>
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Discover True Collaborative Teamwork</b><br>
We have an ambitious set of goals, but our confidence &ndash; and our inspiration &ndash; stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.<br>
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We&rsquo;re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.<br>
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<b>Rewards &amp; Benefits</b>
</div>Time Off &amp; Work-Life Balance: Flexible Time Off Paid Parental &amp; Medical Leave<ul><li> Paid Company Holidays</li>
<li>Health &amp; Wellness:<b> </b>Fertility &amp; Family Building Benefits Medical, Dental, and Vision Insurance Employee Assistance Program (EAP) Life Insurance Short- and Long-Term Disability Coverage</li>
<li>Financial Security:<b> </b>Equity 401(k) with Company Match Identity Theft Protection</li>
<li>And More!</li></ul><br>
<h3 class="jobSectionHeader"><b>
About Kriya Therapeutics</b></h3><div>
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Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.</i></div><div><i>
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All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.</i></div></div>

Associate Director, Clinical Data Management Lead

Join Kriya Therapeutics and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Kriya Therapeutics

About Company

Associate Director, Clinical Data Management Lead