Associate Director, Clinical Data Management

<p></p> <p><strong>The Opportunity:</strong></p> <p><span data-contrast="none">As Associate Director, Data Management, you will be accountable for delivery, integrity, and quality of Relay’s clinical data across the clinical studies. You will be an integrated member of the Relay Tx scientific team, responsible for the in-house data management expertise for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients. You will report to the Senior Director, Clinical Data Management. </span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p> <p><strong><span data-contrast="auto">Your Role: </span></strong><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">You will be responsible for oversight and execution of data management activities for assigned clinical programs including data timelines and key deliverables. </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">You will work directly with and oversee CROs and vendors for outsourced Data Management activities. Is responsible for CRO performance and data management metrics for assigned programs.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">You will lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals. </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">You will lead data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP).</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">You will be responsible for executing or overseeing data cleaning activities through to database lock: includes generating and managing clinical trial data queries, data review listings, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events and central labs. </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">You will collaborate with a dynamic Relay cross-functional team to ensure timeliness and quality of data deliverables.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">You will ensure compliance with global regulatory requirements and quality standards.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">You will contribute to data standards including CRF and participate in data system development initiatives and database integration projects.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">You will participate in SOP development, training of junior data managers, process mapping, and other departmental activities.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p> <p><strong><span data-contrast="auto">Your Background: </span></strong><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">You should ideally have 7+ years of experience in the pharmaceutical / biotechnology industry as a Data Manager.  Sponsor experience is strongly preferred.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">You have advanced experience with data collection and cleaning covering Phase I, II and III studies. Oncology experience is preferred.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">You have experience in executing clinical studies across various phases is desirable.  Expertise in oncology drug development is preferred.        </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">You have a strong and current knowledge in global regulatory and compliance requirements including but not limited to US CFR, EU CTD, ICH GCP, and CDISC.      </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">You have experience in CRO and vendor oversight.         </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">You are a creative problem-solver with excellent communication and public speaking skills.         </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">You have strong interpersonal and organizational skills, with a high degree of attention to detail.      </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">You are pragmatic and able to manage multiple projects and needs effectively.</span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559685":1200,"335559739":0,"335559740":240}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p> <p><strong>Estimated Salary Range</strong>: [$146,000 - $208,000].</p> <p>The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.</p> <p>#BP1</p><div class="content-conclusion"><p><strong>About Relay Therapeutics</strong></p> <p><span data-contrast="auto">Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto">Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p> </p> <p> </p></div>