Is the Associate Clinical Trial Manager position at 4D Molecular Therapeutics fully remote?

Yes, this Associate Clinical Trial Manager position at 4D Molecular Therapeutics is a remote position. The role is available for candidates in United States.

Is this a full-time or part-time Associate Clinical Trial Manager role?

This is a full-time Associate Clinical Trial Manager position at 4D Molecular Therapeutics.

What is the salary range for the Associate Clinical Trial Manager position?

The salary range for this Associate Clinical Trial Manager role is $117k - $132k.

How do I apply for the Associate Clinical Trial Manager position at 4D Molecular Therapeutics?

You can apply for this Associate Clinical Trial Manager position by clicking the "Apply Now" button on this page, which will take you to 4D Molecular Therapeutics's application portal.

Associate Clinical Trial Manager at 4D Molecular Therapeutics

United States

$117k - $132k

<div class="content-intro">Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.   4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery</div>GENERAL SUMMARY:    4DMT seeks a motivated and experienced Associate Clinical Trial Manager support the Company's clinical trial activities.  This position will be responsible for supporting the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close-out activities.  This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines.  This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.   MAJOR DUTIES & RESPONSIBILITIES:     <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF) </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes) </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Assist with the development of site tools and clinical trial start-up activities  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Assist in tracking of trial IP and development of Pharmacy Manuals  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1">Participate in study vendor set up and specification process, as appropriate  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1">Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1">Assist with tracking of clinical trial progress including status update reports, as requested  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="16" data-aria-level="1">Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="17" data-aria-level="1">Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="18" data-aria-level="1">Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1">May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="20" data-aria-level="1">Willing to travel as business needs demand (<5% anticipated) </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="21" data-aria-level="1">Other duties as may be assigned   </li> </ul> QUALIFICATIONS:    Education:   <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="22" data-aria-level="1">B.A./B.S. degree required </li> </ul> Experience:   <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="23" data-aria-level="1">At least 5 years of work experience supporting clinical trials </li> </ul> Other Qualifications/Skills:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="24" data-aria-level="1">Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="25" data-aria-level="1">Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="26" data-aria-level="1">Ability to prioritize and manage competing priorities </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":90,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="27" data-aria-level="1">Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners </li> </ul>  Travel: 30%   Physical Requirements and Working Conditions:  <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":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. </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":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met. </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":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). </li> </ul>  Base salary compensation range: $117,000 - 132,000 Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.        <div class="content-conclusion"><div>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.</div> <div> </div> <div>Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities</div></div>

Apply Now

Remote Opportunity

Associate Clinical Trial Manager

Join 4D Molecular Therapeutics as a senior professional working remotely from United States. Explore the role, benefits, and apply in one place.

Associate Clinical Trial Manager

4D Molecular Therapeutics

Full Time

$117k - $132k

2 months ago

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition.

United States

Engineering

Senior

Clinical Trial Operations

ICH GCP Guidelines

Regulatory Compliance

+5 more

Job Description

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY:  

4DMT seeks a motivated and experienced Associate Clinical Trial Manager support the Company's clinical trial activities. This position will be responsible for supporting the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close-out activities. This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.

MAJOR DUTIES & RESPONSIBILITIES:   

Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management

Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing

Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)

Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking

Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers

Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines

Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes)

Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)

Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance

Assist with the development of site tools and clinical trial start-up activities

Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations

Assist in tracking of trial IP and development of Pharmacy Manuals

Participate in study vendor set up and specification process, as appropriate

Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities

Assist with tracking of clinical trial progress including status update reports, as requested

Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking

Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation

Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates

May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues

Willing to travel as business needs demand (<5% anticipated)

Other duties as may be assigned

QUALIFICATIONS:  

Education:

B.A./B.S. degree required

Experience:

At least 5 years of work experience supporting clinical trials

Other Qualifications/Skills:

Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements

Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook

Ability to prioritize and manage competing priorities

Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners

Travel: 30%

Physical Requirements and Working Conditions:

Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.

Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $117,000 - 132,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Skills

Clinical Trial Operations

ICH GCP Guidelines

Regulatory Compliance

Trial Master File Management

Clinical Trial Start-Up

Vendor management

Data Tracking

Regulatory document review

Ready to Apply?

Join 4D Molecular Therapeutics today

Salary Range

$117k - $132k

Posted 2 months ago

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Yuno

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15 hours ago

Remote, Latam, Full Time, Individual Contributor, +4 years of experience Who We Are At Yuno, we are building the payment infrastructure that allows all companies to participate in the global market.

Mexico

France

Engineering

Backend Engineering

Mid

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Technical implementation

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Technical Program Manager – SAP Signavio

Tech Mahindra (America's) Inc

Full Time

$120k - $160k

15 hours ago

Technical Program Manager – SAP Signavio Location: Remote US Employment: Full Time We are looking for an experienced Technical Program Manager (TPM) – SAP Signavio to lead enterprise process transformation initiatives within our clients’ ecosystem.

United States

Operations

Senior

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BPMN 2.0

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Senior Editor, Conferences & Events

Bionews, Inc.

Full Time

15 hours ago

<h1>About the Role</h1>Bionews is looking for a Senior Editor to build and lead the editorial strategy and content programming across live and virtual rare disease conferences and events.

United States

Engineering

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Senior

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Key Account Manager NA

Yuno

Full Time

15 hours ago

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Mexico

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