The Clinical Trial Manager will support the Company's clinical trial activities. This position ... Negotiate and finalize site contracts and budgets * Perform and manage data review process on an ...
The Clinical Trial Manager will support the Company's clinical trial activities. This position ... Negotiate and finalize site contracts and budgets * Perform and manage data review process on an ...
Clinical Trial Liaison Manager
Bridgewater, NJ · On-site +1
Medical
Dental
Vision
Life
Retirement
PTO
Clinical trials in North America Overview The Clinical Trial Liaison Manager (CTLM) is a Hybrid ... remote and onsite) Oversees the activities of local CRO teams to ensure effective sponsor oversight ...
Clinical Trial Liaison Manager
Bridgewater, NJ · On-site +1
Medical
Dental
Vision
Life
Retirement
PTO
Clinical trials in North America Overview The Clinical Trial Liaison Manager (CTLM) is a Hybrid ... remote and onsite) Oversees the activities of local CRO teams to ensure effective sponsor oversight ...
Senior Clinical Trial Manager
Cambridge, MA · On-site +1
Perform clinical research site activities, which can include onsite or remote monitoring, co ... or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to ...
Quick apply
Senior Clinical Trial Manager
Cambridge, MA · On-site +1
Perform clinical research site activities, which can include onsite or remote monitoring, co ... or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to ...
Global Clinical Trial Leader
South San Francisco, CA · Remote
$80 - $89.58/hr
Medical
Dental
Vision
Life
Retirement
Global Clinical Trial Leader Location: South San Francisco, CA Type ... Contract Compensation: $80-89.58 Contractor Work Model: Hybrid - onsite and remote Hours: Monday ...
Quick apply
Global Clinical Trial Leader
South San Francisco, CA · Remote
$80 - $89.58/hr
Medical
Dental
Vision
Life
Retirement
Global Clinical Trial Leader Location: South San Francisco, CA Type ... Contract Compensation: $80-89.58 Contractor Work Model: Hybrid - onsite and remote Hours: Monday ...
Clinical Trial Manager
Covington, KY · Remote
Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and ... May conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre ...
Clinical Trial Manager
Covington, KY · Remote
Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and ... May conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre ...
Senior Clinical Trial Manager
Boston, MA · On-site +1
Medical
Dental
Vision
Life
Retirement
The Perfect Addition to Our Team You are excited about the opportunity to spearhead clinical trial ... This is a US based remote position, with preference given to local New England based candidates.
Senior Clinical Trial Manager
Boston, MA · On-site +1
Medical
Dental
Vision
Life
Retirement
The Perfect Addition to Our Team You are excited about the opportunity to spearhead clinical trial ... This is a US based remote position, with preference given to local New England based candidates.
Clinical Trial Manager
Covington, KY · On-site +1
Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and ... May conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre ...
Clinical Trial Manager
Covington, KY · On-site +1
Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and ... May conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre ...
Remote US or Canadian based. We are seeking candidates with either CAR T or Ophthalmology ... and contract, ensuring quality, compliance and meeting country-specific commitments. The role ...
Remote US or Canadian based. We are seeking candidates with either CAR T or Ophthalmology ... and contract, ensuring quality, compliance and meeting country-specific commitments. The role ...
Clinical Trial Recruiter
Champaign, IL · On-site +1
Medical
Dental
Vision
Life
PTO
As a Clinical Trial Recruiter, you will play a pivotal role in advancing medical science by ... Conduct thorough remote screenings and assessments to determine initial patient eligibility for ...
Clinical Trial Recruiter
Champaign, IL · On-site +1
Medical
Dental
Vision
Life
PTO
As a Clinical Trial Recruiter, you will play a pivotal role in advancing medical science by ... Conduct thorough remote screenings and assessments to determine initial patient eligibility for ...
Senior Clinical Trial Manager
Blue Bell, PA · Remote
Medical
Dental
Vision
Life
Retirement
Senior Clinical Trial Manager (Oncology) - Remote, US ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients ...
Senior Clinical Trial Manager
Blue Bell, PA · Remote
Medical
Dental
Vision
Life
Retirement
Senior Clinical Trial Manager (Oncology) - Remote, US ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients ...
The Clinical Trial Manager (CTM) works closely with various internal team members and vendors as ... remote Powered by JazzHR 1NM7USWUK0
Quick apply
The Clinical Trial Manager (CTM) works closely with various internal team members and vendors as ... remote Powered by JazzHR 1NM7USWUK0
Clinical Trial Manager, Immunology
Fort Lauderdale, FL · On-site +1
$145K - $165K/yr
The Clinical Trial Manager (CTM) works closely with various internal team members and vendors as ... remote
Clinical Trial Manager, Immunology
Fort Lauderdale, FL · On-site +1
$145K - $165K/yr
The Clinical Trial Manager (CTM) works closely with various internal team members and vendors as ... remote
Clinical Trial Psych Rater
Carlsbad, CA · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Clinical Trial Psych Rater
Carlsbad, CA · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Clinical Trial Psych Rater
Colton, CA · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Clinical Trial Psych Rater
Colton, CA · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Senior Clinical Trial Manager
Blue Bell, PA · Remote
Medical
Dental
Vision
Life
Retirement
Senior Clinical Trial Manager (Oncology) - Remote, US ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients ...
Quick apply
Senior Clinical Trial Manager
Blue Bell, PA · Remote
Medical
Dental
Vision
Life
Retirement
Senior Clinical Trial Manager (Oncology) - Remote, US ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients ...
Clinical Trial Manager
San Francisco, CA · On-site +1
$140K - $170K/yr
The Clinical Trial Manager (CTM) is a key member of the Clinical Operations team and will report ... This position is for remote work and may require domestic or international travel up to 25% (as ...
Clinical Trial Manager
San Francisco, CA · On-site +1
$140K - $170K/yr
The Clinical Trial Manager (CTM) is a key member of the Clinical Operations team and will report ... This position is for remote work and may require domestic or international travel up to 25% (as ...
Clinical Trial Psych Rater
Gilbert, AZ · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Clinical Trial Psych Rater
Gilbert, AZ · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Associate Director, Clinical Trial Management
San Francisco, CA · On-site +1
$179K - $200K/yr
Medical
Dental
Vision
Retirement
Develop, implement, and provide oversight of vendor budgets and contracts * Tracking and reporting ... Benefits: * A stimulating and rewarding workplace includes flexible work schedules, remote ...
Associate Director, Clinical Trial Management
San Francisco, CA · On-site +1
$179K - $200K/yr
Medical
Dental
Vision
Retirement
Develop, implement, and provide oversight of vendor budgets and contracts * Tracking and reporting ... Benefits: * A stimulating and rewarding workplace includes flexible work schedules, remote ...
Remote US or Canadian based. We are seeking candidates with either CAR T or Ophthalmology ... and contract, ensuring quality, compliance and meeting country-specific commitments. The role ...
Remote US or Canadian based. We are seeking candidates with either CAR T or Ophthalmology ... and contract, ensuring quality, compliance and meeting country-specific commitments. The role ...
Clinical Trial Psych Rater
Gilbert, AZ · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Clinical Trial Psych Rater
Gilbert, AZ · Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... clinical trial data. This position involves reviewing scales administered by raters to confirm ...
Contract Remote Clinical Trial information
See salary details
$17.31 - $22.12
4% of jobs
$22.12 - $26.92
8% of jobs
$26.92 - $31.73
12% of jobs
$31.88 is the 25th percentile. Wages below this are outliers.
$31.73 - $36.54
26% of jobs
$36.54 - $41.35
18% of jobs
$43.02 is the 75th percentile. Wages above this are outliers.
$41.35 - $46.15
19% of jobs
$46.15 - $50.96
6% of jobs
$50.96 - $55.77
2% of jobs
$55.77 - $60.58
1% of jobs
$60.58 - $65.38
1% of jobs
$65.38 - $70.19
2% of jobs
$17
$39
$70
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Job description
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:
The Clinical Trial Manager will support the Company's clinical trial activities. This position reports to the Director of Clinical Operations. This will be responsible for management of the day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities.
MAJOR DUTIES & RESPONSIBILITIES:
Trial Management:
- Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial
- Lead cross-functional study execution team in support of study deliverables
- Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
- Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
- Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
- Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files
- Participates in service provider selection process as a part of outsourcing activities
- Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required
- Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations
- Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
- Manage clinical trial budgets, providing ongoing financial reporting and projections
- Negotiate and finalize site contracts and budgets
- Perform and manage data review process on an ongoing basis
- Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed
- Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues
- Ensures tracking and review of protocol deviations and assesses impact on study data
- Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget
- Provides oversight for forecasting of clinical supplies, including study drug and supplies
Department Management:
- May manage and/or oversee work of junior Clinical Operations staff
- May support development and review of Clinical SOPs and other department initiatives
- Travel as needed to sites, conferences, industry meetings
- Other duties as may be assigned
QUALIFICATIONS:
Education:
- B.A./B.S. degree in Science
Experience:
- 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting a retina clinical trial
- Global APAC experience desired
Other Qualifications/Skills:
(non-technical and technical skills)
- Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills
- Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
- Proven clinical operational skills to direct protocol execution to ensure timeline, budget and quality metrics are met
- Excellent communication skills to effectively disseminate information to project team and outside parties
- Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
- Clinical research knowledge and cross-functional understanding of clinical trial methodology
- Excellent organizational, conflict resolution, prioritization and negotiation skills
- Proven ability in creative problem-solving and exercising sound judgment
- Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
- Ability to handle a high volume of highly complex tasks within a given timeline
- Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
- Working knowledge of MS Project for development and update of clinical study timelines
Travel: 5%
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: $150,000 - 170,000
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
About 4D Molecular Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1 - 10 Employees
Headquarters location
Emeryville, CA, US
Year founded
2013