Clinical Trial Manager/Senior Clinical Trial Manager
SeniorClinical DevelopmentNeurology
$130K - $150K/yr(estimated)
Description
<p>Axsome Therapeutics&nbsp;is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in&nbsp;the&nbsp;United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at&nbsp;<a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D9IV8MzSvfOHVeWvrQ7Gpyyjf8oh2YbOImEae8XHfJeeKdWb5iMTG_i6gTGCiHtoMzE1iVTUEQk7IBNDvtrd8dbwJfMAYLK1NiNGH8FOf8LVClDRvtC2QLJLwxcJsj8r1Ife70mjBMpRU8D5q5PfAvDP5AbMwldlIcg5842srmwDavyrAg8tK_VpiNRaKqPlOSPLrCg1Yr2Gqdo5K6iwgZGVlm_WvFI8bMuPXMrqlgRQ%3D&amp;data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639171980%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=dWf%2FLVmCejjY3pM4XQok9nH8pF%2BfGwqWCZ8QwdWpTGQ%3D&amp;reserved=0"><strong>www.axsome.com</strong></a>&nbsp;and follow us on&nbsp;<a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DgkOAMVaudmIbjNO4LWBtZ25_8dkwL1L91EK22smznktgIMuoh5PltUd03J1ZN68KtUufEmLQRMgUjKqoa2Pb1ADSKI0zgay-rDcXd0R2wsbi9WIetngm8x8P1QX9OxhZQzuoPJMXr0UXnyGnIAbSvjwOT0oODGh2y6eODJbInNknBhQ4fXiSCd0LwP8PlS9T_Er2Q-RAoqsN_pVSx0k80cO9ivcvtqdJxZGSzZ37Ytmfmq-AThjSdP9ltWSUa2Fx&amp;data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639206174%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=ZofAOfLit%2FDztSC9U2W1xpx9HHF9z5bb4r1JDK9%2FVzo%3D&amp;reserved=0"><strong>LinkedIn</strong></a>&nbsp;and&nbsp;<a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DU4SjZsngAmgWDPNMBXhPfrWmLydithQ9boBRvsxUVxU58ik7Xm8tTepHofb6vjZMJpx1MvqLvCWWZ1wdmggQxeoNBfHWoTcIMhguJ4Da2DlcZj5Ye9BIcFvHHFTGURb_iGqk28bMXOs7pE8QmOShf7wSgJ0OVuMRyY31jlih0__WG9Q4dmEjE86yUY_8J0qo&amp;data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639221688%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=Y85uAjK%2B8ysZNvbrHQAmApGPYT7mUKwtYyw%2FV0cvCcE%3D&amp;reserved=0"><strong>X</strong></a>.</p>
<p><strong>About This Role:</strong></p>
<p><span data-contrast="none">Axsome&nbsp;Therapeutics is seeking a&nbsp;Clinical Trial Manager/Senior Clinical Trial Manager&nbsp;who will be the&nbsp;primary operational&nbsp;lead&nbsp;for&nbsp;a&nbsp;study and&nbsp;will&nbsp;lead the cross-functional team for execution of the study. The Clinical Trial Manager/Senior Clinical Trial Manager&nbsp;provides operational leadership to the&nbsp;study team&nbsp;to ensure project milestones deliver on time, within budget, high quality, and in compliance with the ICH / GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed.</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><em><span data-contrast="auto">This role is based at&nbsp;Axsome’s&nbsp;HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.&nbsp;&nbsp;</span></em><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><strong>Job Responsibilities and Duties</strong>&nbsp;include, but are not limited to, the following:</p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Responsible for&nbsp;leading&nbsp;all operational aspects and progress of clinical trial&nbsp;which can include but is not limited&nbsp;to:&nbsp;study planning activities;&nbsp;study execution including ongoing tracking&nbsp;of&nbsp;all applicable performance metrics;&nbsp;and quality indicators</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Serve as an escalation point and resource for study team and investigative&nbsp;sites</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Facilitate&nbsp;and review&nbsp;the&nbsp;site feasibility&nbsp;process&nbsp;and&nbsp;oversee&nbsp;the&nbsp;site&nbsp;selection processes</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Oversee subject recruitment&nbsp;/&nbsp;retention strategy and related initiatives</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Provide operational input&nbsp;for&nbsp;study documents such as&nbsp;synopsis,&nbsp;and&nbsp;protocol,&nbsp;and&nbsp;develops/approves&nbsp;ICFs, CRFs, CRF Completion Guidelines,&nbsp;study&nbsp;plans, including Clinical Monitoring Plan,&nbsp;Protocol Deviation Plan, Risk Management Plan,&nbsp;etc.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Develop protocol training materials for CRAs and&nbsp;site-facing&nbsp;materials for SEVs, SIVs and ad-hoc training</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Responsible for oversight of&nbsp;study&nbsp;teams in review of clinical data&nbsp;in conjunction with Data Management; provides guidance on issues&nbsp;/&nbsp;queries as needed and implements risk management concepts as appropriate</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">In conjunction with&nbsp;the&nbsp;Lead CRA,&nbsp;this position will&nbsp;be responsible for&nbsp;motivating&nbsp;and leading&nbsp;the assigned clinical monitoring team to deliver on study timelines and milestone deliverables</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Oversee monitoring visit schedule to ensure compliance with frequency&nbsp;set forth in&nbsp;CMP</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="none">Review site monitoring visit reports for clarity and completeness and escalates issues&nbsp;identified&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="none">Participate&nbsp;in clinical vendor selection process as a part of outsourcing activities</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="none">Assist&nbsp;in the review and approval of vendor and site budgets along with the study director</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="none">Provide oversight&nbsp;for&nbsp;all&nbsp;clinical&nbsp;vendor activities (e.g.,,&nbsp;specifications development, UATs, issues escalations, KPIs)</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="none">Work closely with QA to drive CAPA review,&nbsp;implementation,&nbsp;and completion</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="15" data-aria-level="1"><span data-contrast="none">Oversee&nbsp;the&nbsp;eTMF set-up, ongoing quality review,&nbsp;and final reconciliation of study documents&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="16" data-aria-level="1"><span data-contrast="none">Ensure that all aspects of GCP compliance and audit/inspection&nbsp;readiness are&nbsp;maintained&nbsp;throughout trial conduct</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="17" data-aria-level="1"><span data-contrast="none">Create, manage, measure, and report timelines for milestone deliverables</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="18" data-aria-level="1"><span data-contrast="none">Proactively manage&nbsp;and&nbsp;identify&nbsp;potential study issues&nbsp;and&nbsp;risks&nbsp;as well as&nbsp;recommend&nbsp;and&nbsp;implement solutions with key internal&nbsp;/&nbsp;external stakeholders</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="19" data-aria-level="1"><span data-contrast="none">Lead&nbsp;internal team meetings, and other trial-specific meetings</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="20" data-aria-level="1"><span data-contrast="none">Participate in the development, review, and implementation of departmental SOPs, initiatives,&nbsp;and processes</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="21" data-aria-level="1"><span data-contrast="none">May conduct Site Evaluation visits (SEVs) and Site Initiation Visits (SIVs)</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="22" data-aria-level="1"><span data-contrast="none">Review&nbsp;and&nbsp;approve vendor invoices for all clinical trial vendors including investigative sites</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<p><strong>Requirements</strong><strong>&nbsp;/ Qualifications</strong></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Bachelor’s&nbsp;degree&nbsp;required;&nbsp;preference to candidates with a scientific background&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">At least 5 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO)&nbsp;for&nbsp;</span><strong><span data-contrast="none">Clinical Trial Manager level</span></strong><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">At least 7 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO) for&nbsp;</span><strong><span data-contrast="none">Senior Clinical Trial Manager level</span></strong><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Preference to candidates with prior small company experience and 1+ years management experience</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Ability to work on site Monday, Tuesday &amp; Thursday. We are unable to consider candidates who are looking for fully remote roles</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<p><strong>Experience and Knowledge:</strong></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations&nbsp;/&nbsp;ICH&nbsp;/&nbsp;GCP guidelines, is&nbsp;required</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Ability to work on complex or multiple projects and exercise independent judgment within&nbsp;generally defined&nbsp;practices and policies&nbsp;that&nbsp;lead to obtaining results</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Strong attention to detail, time&nbsp;management&nbsp;and excellent organizational skills</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Strong interpersonal skills and communication skills (both written and oral)</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Ability to problem solve,&nbsp;delegate&nbsp;appropriate tasks,&nbsp;work within a team&nbsp;environment&nbsp;and mentor junior team members such as CTAs/CRAs.&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Excellent sense of urgency to deliver at/surpass study conduct targets</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Strong leadership skills, self-motivated, adaptable to a dynamic environment</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Preference to energetic candidates with a desire to think “outside the box”</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
<li><span data-contrast="none">Willingness to travel as needed, up to 20%&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<p><strong>Salary and Benefits:</strong></p>
<p>The anticipated salary range for this role is $130,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.</p>
<p><em><span class="TextRun SCXW121232697 BCX8" lang="EN-CA" data-contrast="none"><span class="NormalTextRun SCXW121232697 BCX8">Axsome</span><span class="NormalTextRun SCXW121232697 BCX8"> is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and </span><span class="NormalTextRun SCXW121232697 BCX8">solicit</span><span class="NormalTextRun SCXW121232697 BCX8"> applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.</span></span></em><span class="EOP SCXW121232697 BCX8" data-ccp-props="{&quot;134233118&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><em>Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration. </em></p>
Axsome Therapeutics
BIOTECHNOLOGY
CNS treatments
LocationNY - New York
Open Jobs182
Neurology
View Company ProfilePipeline
SunosiN/A
Solriamfetol 150 mg Oral TabletPhase 1
SolriamfetolPhase 2
AXS-12Phase 2
AXS-05Phase 2