Associate Director, Clinical Data Management

<p><span data-contrast="none">Remix Therapeutics is a clinical-stage biopharmaceutical company that has pioneered a new class of small molecule medicines targeting the RNA splicing machinery — correcting the disease-causing errors that drive cancers and other serious conditions at their source. </span><span data-ccp-props="{"335559738":60,"335559739":60}"> </span></p>
<p><span data-contrast="none">REM-422 is our lead program currently focused on developing a therapy for Adenoid Cystic Carcinoma (ACC), a rare cancer for which there is no approved therapy. REM-422 is concurrently being evaluated as a treatment for AML/.HR-MDS with aspirations to evolve into other oncology indications with high unmet need. REM-422 is at a critical inflection point in its clinical development and Remix is building the team to bring this novel molecule forward as a medicine for patients.</span><span data-ccp-props="{"335559738":60,"335559739":60}"> </span></p>
<p><strong>Position Summary:</strong></p>
<p><span class="TextRun SCXW267576908 BCX0" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW267576908 BCX0">Remix is seeking a</span><span class="NormalTextRun SCXW267576908 BCX0">n Associate Director, </span><span class="NormalTextRun SCXW267576908 BCX0">Clinical </span><span class="NormalTextRun SCXW267576908 BCX0">Data Management </span><span class="NormalTextRun SCXW267576908 BCX0">to </span><span class="NormalTextRun SCXW267576908 BCX0">provide technical </span><span class="NormalTextRun SCXW267576908 BCX0">expertise</span><span class="NormalTextRun SCXW267576908 BCX0"> and vendor oversight </span><span class="NormalTextRun SCXW267576908 BCX0">at a pivotal moment for REM-422 and the ACC patients we serve. Reporting to the SVP, Clinical </span><span class="NormalTextRun SCXW267576908 BCX0">Development </span><span class="NormalTextRun SCXW267576908 BCX0">Operations & Patient Advocacy and based at our Watertown, MA headquarters, this </span><span class="NormalTextRun SCXW267576908 BCX0">role is the first to be solely dedicated to the Clinical Data Management function. </span><span class="NormalTextRun SCXW267576908 BCX0">Accordingly</span><span class="NormalTextRun SCXW267576908 BCX0">, the role will </span><span class="NormalTextRun SCXW267576908 BCX0">be responsible for</span><span class="NormalTextRun SCXW267576908 BCX0"> developing</span><span class="NormalTextRun SCXW267576908 BCX0"> and executing</span><span class="NormalTextRun SCXW267576908 BCX0"> Remix standards and processes tailored to the oversight of outsourced solutions suitable for Registration programs as well as early development programs to follow.</span></span><span class="EOP Selected SCXW267576908 BCX0" data-ccp-props="{"335559738":60,"335559739":60}"> </span></p>
<p><strong>Key Responsibilities:</strong></p>
<p><strong><span data-contrast="auto">CRO & Vendor Management</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></strong></p>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Oversight & Accountability: Manage and provide robust operational oversight of functional deliverables from data management CROs and specialized vendors (e.g., central labs, ePRO, IRT).</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Governance & Metrics: Establish and monitor CRO performance metrics, Key Performance Indicators (KPIs), and quality metrics. Lead routine governance and alignment meetings to track study progress and resolve data issues.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Financial Control: Participate in CRO selection, Request for Proposal (RFP) evaluations, and bid defense meetings. Review and manage the DM vendor budget, including the evaluation of Statements of Work (SoW) and potential Change Orders.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Deliverable Approval: Critically review and approve core vendor deliverables, including Data Management Plans (DMPs), Case Report Form (eCRF) designs, Edit Check Specifications, User Acceptance Testing (UAT) setups, and Data Transfer Specifications.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<p><strong><span data-contrast="auto">Data Management Operations & Quality Assurance</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></strong></p>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Trial Lifecycle Leadership: Lead data management activities from initial protocol review and study start-up through database cleaning, lock, and archival.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Data Integrity & Review: Conduct ongoing data reviews via data listings and visualization tools to identify data anomalies, trends, and systemic risks across clinical programs.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Compliance & Inspection Readiness: Ensure all data operations strictly adhere to ICH-GCP guidelines, corporate SOPs, and regulatory expectations. Serve as the Data Management Subject Matter Expert (SME) during internal audits and Health Authority inspections.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Standardization: Collaborate on the design and maintenance of corporate data standards (e.g., CDISC/CDASH) to ensure downstream compatibility for biostatistics and electronic submissions.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<p><strong><span data-contrast="auto">Cross-Functional Leadership</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></strong></p>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Study Team Representation: Serve as the primary Data Management representative on Trial Management Teams.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Stakeholder Alignment: Actively partner with Biostatistics, Statistical Programming, Clinical Operations, Medical Writing, and Regulatory Affairs to ensure data management timelines align seamlessly with broader corporate objectives.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<p><strong>Qualifications:</strong></p>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Education: BS/BA in a scientific, informatics, or healthcare discipline (Master’s or Ph.D. preferred).</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">A minimum of 8+ years of experience in clinical drug development directly focused on Clinical Data Management within a pharmaceutical, biotech, or CRO environment.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto">Deep expertise in industry-standard Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Veeva Vault CDMS).</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto">Advanced knowledge of global regulatory frameworks, including ICH-GCP, FDA guidelines, EMA requirements, and CDISC standards.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1"><span data-contrast="auto">Proven track record of successfully managing full-service data management CROs and external vendors for complex or multi-center clinical trials.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="16" data-aria-level="1"><span data-contrast="none">Deep oncology or rare disease trial experience preferred.</span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="17" data-aria-level="1"><span data-contrast="none">Experience supporting clinical programs from IND through NDA submission and regulatory approval, including registrational trials and Inspection Readiness.</span></li>
</ul>
<ul>
<li data-leveltext="•" data-font="Arial" data-listid="2" data-list-defn-props="{"335551500":43421,"335552541":1,"335559685":540,"335559991":260,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="18" data-aria-level="1"><span data-contrast="none">Operates well in ambiguity; makes sound decisions with incomplete information; moves quickly without cutting corners and brings the team with them.</span><span data-ccp-props="{"335559738":50,"335559739":50}"> </span></li>
</ul>
<p><strong>Salary Range:</strong></p>
<p><span class="TextRun SCXW232710140 BCX0" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW232710140 BCX0">$187,000 - $230</span><span class="NormalTextRun SCXW232710140 BCX0">,000 USD</span></span><span class="EOP Selected SCXW232710140 BCX0" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":60,"335559739":60,"335559740":259}"> </span></p>
<p>This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable.  Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.</p>
<p> </p>