Praxis Precision Medicines, Inc.

Senior Clinical Trial Manager (CTM)

United States - Remote Full-time Remote

Job Description

Senior&nbsp;Clinical&nbsp;Trial&nbsp;Manager&nbsp;(CTM)&nbsp;

Location:&nbsp;&nbsp;&nbsp;This position may be performed remotely with travel to the Boston area as needed.&nbsp;&nbsp;&nbsp;

Position Summary&nbsp;

This&nbsp;role&nbsp;will&nbsp;be&nbsp;responsible&nbsp;for&nbsp;project&nbsp;management&nbsp;in&nbsp;the&nbsp;initiation,&nbsp;execution&nbsp;and&nbsp;close&nbsp;out&nbsp;of&nbsp;domestic&nbsp;and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation.&nbsp;

This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing&nbsp;new approaches&nbsp;to conducting research to support data aggregation and analysis&nbsp;to&nbsp;advance&nbsp;patient&nbsp;care.&nbsp;The&nbsp;Sr.&nbsp;CTM&nbsp;will&nbsp;participate&nbsp;on&nbsp;clinical&nbsp;project&nbsp;teams&nbsp;to&nbsp;achieve&nbsp;quality&nbsp;results in a cost-effective and&nbsp;timely&nbsp;manner.&nbsp;S/he&nbsp;will be a key team member to&nbsp;establish&nbsp;key practices and procedures for the clinical team.&nbsp;

Primary&nbsp;Responsibilities&nbsp;

<ul>

<li>Manage&nbsp;study&nbsp;activities&nbsp;in&nbsp;the&nbsp;successful&nbsp;execution&nbsp;of&nbsp;clinical&nbsp;trials&nbsp;from&nbsp;protocol&nbsp;concept&nbsp;to&nbsp;clinical study report,&nbsp;complying with&nbsp;Good Clinical Practice (GCP) guidelines and international regulations<span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559737&quot;:430,&quot;335559738&quot;:84,&quot;335559740&quot;:237,&quot;469777462&quot;:[831,832],&quot;469777927&quot;:[0,0],&quot;469777928&quot;:[1,1]}">&nbsp;</li>

<li>Manage&nbsp;strategic&nbsp;engagement&nbsp;with&nbsp;key&nbsp;collaborators&nbsp;</li>

<li>Set-up&nbsp;and&nbsp;oversee&nbsp;clinical&nbsp;trial-related&nbsp;trackers&nbsp;such&nbsp;as&nbsp;regulatory&nbsp;documents,&nbsp;trial&nbsp;master&nbsp;file&nbsp;(TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc.&nbsp;</li>

<li>Key&nbsp;contributor&nbsp;to&nbsp;IRB/EC&nbsp;and&nbsp;regulatory&nbsp;submissions&nbsp;</li>

<li>Oversee&nbsp;TMF&nbsp;reviews&nbsp;to&nbsp;ensure&nbsp;completeness&nbsp;and&nbsp;inspection&nbsp;readiness&nbsp;</li>

<li>Regularly&nbsp;review&nbsp;documents&nbsp;to&nbsp;ensure&nbsp;adherence&nbsp;to&nbsp;Clinical&nbsp;Operations&nbsp;and/or&nbsp;project&nbsp;specific&nbsp;quality requirements (e.g.&nbsp;SOPs, work practices, training guides)&nbsp;</li>

<li>Identify&nbsp;and&nbsp;mitigate&nbsp;against&nbsp;study&nbsp;risks,&nbsp;escalating&nbsp;as&nbsp;necessary&nbsp;</li>

<li>Direct&nbsp;initiatives&nbsp;to&nbsp;identify&nbsp;and&nbsp;implement&nbsp;best&nbsp;practices&nbsp;and&nbsp;continuous&nbsp;improvement&nbsp;plans&nbsp;in clinical development&nbsp;</li>

</ul>

Education&nbsp;and&nbsp;Professional&nbsp;Experience&nbsp;

<ul>

<li>Bachelor’s&nbsp;degree&nbsp;in&nbsp;a&nbsp;scientific&nbsp;field&nbsp;required;&nbsp;advanced&nbsp;scientific&nbsp;degree&nbsp;a&nbsp;plus&nbsp;</li>

<li>5+&nbsp;years&nbsp;directly&nbsp;managing&nbsp;clinical&nbsp;trials&nbsp;in&nbsp;Sponsor&nbsp;or&nbsp;CRO&nbsp;setting&nbsp;</li>

<li>In-depth&nbsp;knowledge&nbsp;of&nbsp;clinical&nbsp;trial&nbsp;operations,&nbsp;ICH,&nbsp;GCP&nbsp;Guidelines&nbsp;and&nbsp;other&nbsp;applicable&nbsp;regulatory&nbsp;requirements&nbsp;</li>

<li>Experience&nbsp;directing&nbsp;members&nbsp;of&nbsp;clinical&nbsp;operations&nbsp;teams&nbsp;</li>

<li>Experience&nbsp;working&nbsp;in&nbsp;a&nbsp;team&nbsp;across&nbsp;multiple&nbsp;functional&nbsp;areas&nbsp;(e.g.,&nbsp;Quality&nbsp;Assurance,&nbsp;Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)&nbsp;</li>

</ul>

Other&nbsp;Essentials&nbsp;and&nbsp;Key&nbsp;Success&nbsp;Factors&nbsp;

<ul>

<li>Intellectual&nbsp;curiosity,&nbsp;innovation&nbsp;and&nbsp;creative&nbsp;problem&nbsp;solving&nbsp;with&nbsp;an&nbsp;entrepreneurial&nbsp;spirit&nbsp;</li>

<li>Ability&nbsp;to&nbsp;think&nbsp;critically&nbsp;in&nbsp;fast-paced&nbsp;projects&nbsp;with&nbsp;a&nbsp;keen&nbsp;sense&nbsp;of&nbsp;urgency&nbsp;and&nbsp;demonstrated&nbsp;ability to problem solve&nbsp;</li>

<li>Self-motivated&nbsp;and&nbsp;able&nbsp;to&nbsp;work&nbsp;autonomously,&nbsp;as&nbsp;well&nbsp;as&nbsp;a&nbsp;member&nbsp;of&nbsp;a&nbsp;collaborative&nbsp;team&nbsp;</li>

<li>Highly-organized&nbsp;and&nbsp;detail-oriented&nbsp;with&nbsp;a&nbsp;passion&nbsp;to&nbsp;deliver&nbsp;quality&nbsp;results&nbsp;</li>

<li>Strong&nbsp;verbal&nbsp;and&nbsp;written&nbsp;communication&nbsp;skills&nbsp;with&nbsp;an&nbsp;ability&nbsp;to&nbsp;build&nbsp;relationships&nbsp;internally&nbsp;and&nbsp;externally&nbsp;</li>

<li>Highest&nbsp;levels&nbsp;of&nbsp;professionalism,&nbsp;confidence,&nbsp;personal&nbsp;values&nbsp;and&nbsp;ethical&nbsp;standards&nbsp;</li>

</ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">Annualized Base Salary</div><div class="pay-range">$168,000&mdash;$188,000 USD</div></div></div><div class="content-conclusion">Compensation &amp; Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. &nbsp;We also provide company-paid life insurance, AD&amp;D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!&nbsp; Company Overview&nbsp;

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.&nbsp; At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.&nbsp; Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity &amp; Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to <a href="mailto:careers@praxismedicines.com">careers@praxismedicines.com</a>. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.</div>

Frequently Asked Questions

What does the Senior Clinical Trial Manager (CTM) role at Praxis Precision Medicines, Inc. involve?

The Senior Clinical Trial Manager (CTM) position at Praxis Precision Medicines, Inc. in United States - Remote is a full-time role. Senior&nbsp;Clinical&nbsp;Trial&nbsp;Manager&nbsp;(CTM)<span...

What skills are required for Senior Clinical Trial Manager (CTM) at Praxis Precision Medicines, Inc.?

Key skills for this role include: Rust, Scala, Express, AWS, GCP, RDS, LLM, IOS, API.

What is the salary for Senior Clinical Trial Manager (CTM) at Praxis Precision Medicines, Inc.?

The salary for this position is not publicly listed. You can negotiate during the interview process. Check Glassdoor or Levels.fyi for estimates.

Is the Senior Clinical Trial Manager (CTM) position at Praxis Precision Medicines, Inc. remote or on-site?

This position is Remote. You can work from anywhere, subject to the employer's remote work policy.

How do I apply for Senior Clinical Trial Manager (CTM) at Praxis Precision Medicines, Inc.?

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About This Role

Senior Clinical Trial Manager (CTM) at Praxis Precision Medicines, Inc. is a full-time management position in United States - Remote. Key skills include Rust, Scala, Express, AWS, GCP, RDS, LLM, IOS. Education: Master's Degree preferred. Experience: 5+ years.

This role is classified as remote and is suitable for senior-level professionals. Ghost Score 25/100 (Probably Active) indicates this listing is probably active with recent employer engagement.

To apply, visit the official application page through the Apply Now button above. SpotChange Jobs provides AI-powered career tools including resume optimization, ATS testing, interview preparation, and salary negotiation assistance.

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