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 ...
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 ...
Clinical Trial Manager
Boston, MA · On-site
$133K - $150K/yr
The Clinical Trial Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. The ideal candidate will embrace a collaborative, innovative culture that ...
Clinical Trial Manager
Boston, MA · On-site
$133K - $150K/yr
The Clinical Trial Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. The ideal candidate will embrace a collaborative, innovative culture that ...
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 ...
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 ...
The Senior Clinical Trial Manager (Sr. CTM) is responsible for providing operational expertise and support for the Clinical Operations team with the day-to-day activities of executing for one or more ...
Quick apply
The Senior Clinical Trial Manager (Sr. CTM) is responsible for providing operational expertise and support for the Clinical Operations team with the day-to-day activities of executing for one or more ...
Clinical Trial Manager
Andover, MA · On-site
POSITION SUMMARY This Clinical Trial Manager role is responsible for leading the end-to-end execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with ...
Clinical Trial Manager
Andover, MA · On-site
POSITION SUMMARY This Clinical Trial Manager role is responsible for leading the end-to-end execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with ...
The Clinical Trial Manager is an experienced clinical operations professional responsible for independently leading the operational execution of global clinical trials within a rapidly growing ...
The Clinical Trial Manager is an experienced clinical operations professional responsible for independently leading the operational execution of global clinical trials within a rapidly growing ...
Clinical Trial Manager
Andover, MA · On-site
POSITION SUMMARY This Clinical Trial Manager role is responsible for leading the end-to-end execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with ...
Clinical Trial Manager
Andover, MA · On-site
POSITION SUMMARY This Clinical Trial Manager role is responsible for leading the end-to-end execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with ...
Clinical Trial Manager
Berkeley, CA · On-site +1
We are seeking a Clinical Trial Manager (CTM) to join our Clinical Operations group. You will be responsible for the operational execution and Sponsor oversight of global clinical trial activities ...
Clinical Trial Manager
Berkeley, CA · On-site +1
We are seeking a Clinical Trial Manager (CTM) to join our Clinical Operations group. You will be responsible for the operational execution and Sponsor oversight of global clinical trial activities ...
Clinical Trial Manager
Berkeley, CA · On-site +1
We are seeking a Clinical Trial Manager (CTM) to join our Clinical Operations group. You will be responsible for the operational execution and Sponsor oversight of global clinical trial activities ...
Clinical Trial Manager
Berkeley, CA · On-site +1
We are seeking a Clinical Trial Manager (CTM) to join our Clinical Operations group. You will be responsible for the operational execution and Sponsor oversight of global clinical trial activities ...
SR. CLINICAL TRIAL MANAGER SutroBiopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross ...
SR. CLINICAL TRIAL MANAGER SutroBiopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross ...
SR. CLINICAL TRIAL MANAGER Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross ...
SR. CLINICAL TRIAL MANAGER Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross ...
Clinical Trial Manager
$100K - $125K/yr
Chair cross functional study team meetings and maintain meeting minutes and action items for team follow-up. * Regularly meet with Manager to discuss overall clinical trial(s) plans, update ...
Clinical Trial Manager
$100K - $125K/yr
Chair cross functional study team meetings and maintain meeting minutes and action items for team follow-up. * Regularly meet with Manager to discuss overall clinical trial(s) plans, update ...
We are seeking an experienced Clinical Trial Manager (CTM)/Senior Clinical Trial Manager (Sr. CTM). Reporting to the VP of Clinical Operations, the CTM/Sr. CTM will be responsible for the end-to-end ...
We are seeking an experienced Clinical Trial Manager (CTM)/Senior Clinical Trial Manager (Sr. CTM). Reporting to the VP of Clinical Operations, the CTM/Sr. CTM will be responsible for the end-to-end ...
Clinical Trial Manager
$133K - $150K/yr
The Clinical Trial Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. The ideal candidate will embrace a collaborative, innovative culture that ...
Clinical Trial Manager
$133K - $150K/yr
The Clinical Trial Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. The ideal candidate will embrace a collaborative, innovative culture that ...
Clinical Trial Manager
Brisbane, CA · Remote
The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study ...
Clinical Trial Manager
Brisbane, CA · Remote
The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study ...
Clinical Trial Manager
San Carlos, CA · On-site
The Clinical Trial Manager (CTM) will manage the day-to-day planning and execution of clinical studies to generate evidence supporting the safety, performance, and clinical utility of novel robotics ...
Clinical Trial Manager
San Carlos, CA · On-site
The Clinical Trial Manager (CTM) will manage the day-to-day planning and execution of clinical studies to generate evidence supporting the safety, performance, and clinical utility of novel robotics ...
Clinical Trial Manager
Redwood City, CA · On-site
As the Clinical Trial Manager of Clinical Operations, initially reporting to the Director, Clinical Operations, you will be responsible for Contract Research Organization (CRO) oversight and ...
Clinical Trial Manager
Redwood City, CA · On-site
As the Clinical Trial Manager of Clinical Operations, initially reporting to the Director, Clinical Operations, you will be responsible for Contract Research Organization (CRO) oversight and ...
Senior/Clinical Trial Manager (CTM)
Boston, MA · On-site
$175K - $195K/yr
Manage all clinical aspects of a clinical trial and ensures trial execution in compliance with ICH/GCP guidelines/regulations and applicable SOPs * Lead and collaborate effectively with cross ...
Senior/Clinical Trial Manager (CTM)
Boston, MA · On-site
$175K - $195K/yr
Manage all clinical aspects of a clinical trial and ensures trial execution in compliance with ICH/GCP guidelines/regulations and applicable SOPs * Lead and collaborate effectively with cross ...
Description SR. CLINICAL TRIAL MANAGER Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating ...
Description SR. CLINICAL TRIAL MANAGER Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating ...
Clinical Trial Manager
Cambridge, MA · On-site
$140K - $168K/yr
RESPONSIBILITIES The Clinical Trial Manager (CTM) works closely with various sponsors, internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted ...
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Clinical Trial Manager
Cambridge, MA · On-site
$140K - $168K/yr
RESPONSIBILITIES The Clinical Trial Manager (CTM) works closely with various sponsors, internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted ...
Merck Clinical Trial Manager information
See salary details
$28.85 - $34.97
4% of jobs
$34.97 - $41.08
6% of jobs
$41.08 - $47.20
7% of jobs
$51.79 is the 25th percentile. Wages below this are outliers.
$47.20 - $53.32
9% of jobs
$53.32 - $59.44
15% of jobs
The median wage is $62.14 / hr.
$59.44 - $65.56
18% of jobs
$69.92 is the 75th percentile. Wages above this are outliers.
$65.56 - $71.68
21% of jobs
$71.68 - $77.80
7% of jobs
$77.80 - $83.92
6% of jobs
$83.92 - $90.03
3% of jobs
$90.03 - $96.15
2% of jobs
$28
$62
$96
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Full-time
This job post has expired today. Applications are no longer accepted.
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. This position may support unmasked activities.
MAJOR DUTIES & RESPONSIBILITIES:
Trial Management:
- Serve as the primary unmasked contact for managing protocol execution, including oversight of the unmasked CRO, other study service providers, and consultants that are involved in a clinical trial
- Serve as the primary sponsor-side unmasked contact for unmasked investigative site personnel
- Support unmasked drug supply and accountability activities including oversight of IWRS system.
- Act as the unmasked liaison between Clinical Operations and Clinical Supply
- 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 the unmasked 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
- 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
- Conduct unmasked study specific training of CRO study staff, monitors, investigational sites, and service providers
- Perform and manage IP 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 unmasked 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