Senior Clinical Trial Manager

7 days ago

Fort Lee, United States Mezzion Full time

Position Title: Senior Clinical Trial Manager

Location: Remote (Corporate Headquarters: Fort Lee, NJ)

Department: Clinical

Classification: Full-Time, Exempt, Salaried

Reports to: Chief Operating Officer


About Us:

Mezzion Pharmaceuticals is a clinical-stage pharmaceutical company dedicated to addressing rare diseases. We are currently focused on developing JURVIGO® (udenafil), which has the potential to become the first approved chronic treatment for approximately 70,000 individuals living with single-ventricle congenital heart disease who have undergone Fontan surgery ("Fontan").


JURVIGO® (udenafil), is a highly selective, oral, and potent phosphodiesterase type 5 inhibitor (PDE5i). With a life expectancy of only 35–45 years, the Fontan population currently has no approved pharmacological treatments. JURVIGO® is designed to enhance cardiovascular physiology and delay disease progression in these patients.


Mezzion is actively enrolling Fontan patients into FUEL-2, a pivotal phase 3 confirmatory trial. As the largest Fontan trial ever undertaken, FUEL-2 spans multiple sites across the United States, Europe, and South Korea.


Position Summary:

We are seeking a Senior Clinical Trial Manager to lead all aspects of clinical trial operations for late-stage studies. This pivotal role involves managing Clinical Research Organizations (CROs) and ensuring that timelines, quality, and budgetary objectives are achieved. Reporting directly to the Chief Operating Officer, the Senior Clinical Trial Manager will play a strategic and hands-on role in shaping our clinical program.


Key Responsibilities:

  • Oversee all operational aspects of Mezzion’s phase 3 clinical programs, including direct management of CROs to ensure timelines and deliverables are met.
  • Provide strategic guidance in the evaluation and selection of CROs and clinical vendors.
  • Lead and manage Clinical Operations to align with quality standards, resource needs, and budget constraints.
  • Establish and monitor performance metrics to ensure successful execution of clinical trials.
  • Integrate clinical operations expertise into development plans, protocols, and study designs.
  • Collaborate with cross-functional teams, project leads, and internal stakeholders.
  • Partner with Clinical Quality Assurance to plan and implement quality checks for compliance with SOPs, ICH-GCP guidelines, and regulatory standards.
  • Support regulatory submissions and participate in interactions with agencies such as the FDA and EMA.
  • Stay informed about competitive clinical practices and regulatory trends to inform development plans.


Qualifications:


Education:

  • Bachelor’s Degree in Nursing (BSN), Health Administration, Life Sciences (Biology, Chemistry, etc…), Public Health and/or Business Administration.
  • Master’s Degree (e.g. MBA, MS or MSN) preferred


Experience:

  • 5-10 years of clinical research experience, including direct project management of phase 3 trials and CRO oversight.
  • Expertise in clinical development operations, strategic planning, and late-stage trial execution.
  • Experience developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, and other regulatory documents.
  • Background in rare diseases, congenital heart disease, or exercise physiology highly desirable.
  • Proficiency in clinical data management and pharmacovigilance is an advantage.


Skills:

  • Proven ability to manage CROs and lead cross-functional teams.
  • Exceptional problem-solving, organizational, and communication skills.
  • Thorough knowledge of FDA regulations, ICH Guidelines, and clinical research standards.
  • Ability to engage with clinical trial sites to optimize enrollment.
  • Self-motivated, results-driven, and adaptable to dynamic environments.


Work Environment:

  • High-growth, fast-paced biotech setting requiring adaptability and initiative.
  • Up to 50% travel, primarily domestic, with occasional international travel.


Mezzion Pharmaceuticals is committed to fostering a collaborative and inclusive work environment. This job description reflects the general scope of responsibilities and may evolve to meet organizational needs.

  • Clinical Trials Manager

    2 weeks ago

    Fort Lee, NJ, United States Global Channel Management, Inc. Full time

    Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function....

  • Clinical Trial Documentation Manager

    5 days ago

    Fort Worth, Texas, United States Source One Technical Solutions Full time

    **Source One Technical Solutions**: A consulting services company seeking a skilled Clinical Trial Documentation Specialist to work as a consultant for a global medical device client in the Fort Worth, TX area (hybrid work schedule).**Job Title:** Technical Documentation Specialist II (Contractor)**Salary Range:** $37.86 - $41.43 per hour (W-2)The initial...

  • Clinical Trials Coordinator

    3 weeks ago

    Fort Worth, Texas, United States Aequor Information Technologies Pvt. Ltd. Full time

    Job DescriptionAt Aequor Information Technologies Pvt. Ltd., we are seeking a highly organized and detail-oriented Clinical Trials Coordinator to join our team.We offer an attractive compensation package of $65,000 per year for this role.Key Responsibilities:Coordinate the collection and processing of trial documents between investigator sites and our...

  • Senior Trial Paralegal

    1 day ago

    Fort Lauderdale, Florida, United States Schlesinger Law Offices, P.A. Full time

    Job Summary:We are seeking a highly motivated and experienced Senior Trial Paralegal to join our team at Schlesinger Law Offices, P.A. in Fort Lauderdale, Florida.The ideal candidate will have a minimum of 5 years of civil litigation/trial prep experience and be proficient in Microsoft Office.The successful candidate will assist Senior Trial Attorneys with...

  • Clinical Trial Documentation Specialist

    4 weeks ago

    Fort Worth, United States Source One Technical Solutions Full time

    Job DescriptionJob DescriptionSource One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Fort Worth, TX (hybrid schedule).Job Title: Technical Documentation Specialist II (Contractor)Pay Range: $37.86/hr - $41.43/hr (W-2)The contract...

  • Regulatory Documentation Coordinator

    4 weeks ago

    Fort Worth, Texas, United States Source One Technical Solutions Full time

    Job Title: Regulatory Documentation Coordinator - Clinical TrialsJob OverviewSource One Technical Solutions, a WBENC certified woman-owned company, provides a full range of professionals to various industries nationwide. We are currently seeking a Regulatory Documentation Coordinator - Clinical Trials for our client in Fort Worth, TX.Key...

  • Data Analyst

    7 days ago

    Fort Worth, Texas, United States NavitsPartners Full time

    Job Summary: NavitsPartners is seeking a skilled Data Analyst - Clinical Trials Specialist to collaborate with our team in Fort Worth, TX. In this role, you will analyze and interpret clinical trial data, developing statistical programs to ensure data integrity and accuracy. About the Role: As a Data Analyst - Clinical Trials Specialist, you will work...

  • Clinical Trials Negotiator

    1 week ago

    Fort Wayne, Indiana, United States Lifelancer Full time

    Job SummaryM3 Wake Research is hiring a Clinical Research Budgets and Contracts Specialist to support our growing business. The successful candidate will have experience in contract negotiation and management, as well as strong analytical and communication skills.This is a full-time remote position with opportunities for professional growth and...

  • Oncology Clinical Trial Coordinator

    3 weeks ago

    Fort Worth, Texas, United States US Oncology, Inc. Full time

    **Overview**Texas Oncology, Inc. is a leading provider of community-based cancer care in the United States. We are seeking an experienced Clinical Research Nurse (RN) to join our team at our Ft Worth location.This full-time position offers a competitive salary of $95,000 per year and a comprehensive benefits package. As a member of our clinical research...

  • Clinical Trial Documentation Specialist II

    1 month ago

    Fort Worth, United States Source One Technical Solutions Full time

    Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Fort Worth, TX (hybrid work schedule).Job Title: Technical Documentation Specialist II (Contractor)Pay Range: $37.86/hr - $41.43/hr (W-2)The contract duration is initially 2...

  • Medical Device Clinical Trial Operations Lead

    3 weeks ago

    Fort Atkinson, Iowa, United States XII Medical Full time

    OverviewXII Medical is a pioneering medical device company dedicated to developing innovative solutions for treating obstructive sleep apnea. Our next-generation neurostimulation system aims to increase patient compliance by reducing surgical invasiveness and improving sleeping habits.About the RoleWe are seeking an experienced Clinical Trials Manager to...

  • Senior Trial Paralegal Specialist

    3 weeks ago

    Fort Lauderdale, Florida, United States Schlesinger Law Offices, P.A. Full time

    About the OpportunityWe are seeking a highly skilled and experienced Senior Trial Paralegal to join our team at Schlesinger Law Offices, P.A. in Fort Lauderdale.The ideal candidate will have a minimum of 5 years of civil litigation/trial prep experience and be proficient in electronic filing and service of case documents, preparation of discovery, trial...

  • Senior Trial Paralegal Coordinator

    3 weeks ago

    Fort Lauderdale, Florida, United States Schlesinger Law Offices, P.A. Full time

    Job OpportunityWe are seeking a seasoned and detail-oriented paralegal to join our team in Fort Lauderdale, Florida. This is an excellent opportunity for a motivated professional to work in a fast-paced environment with a renowned personal injury law firm.About UsSchlesinger Law Offices, P.A. is a multi-generational firm with over seven decades of experience...

  • Licensed Clinical Social Worker, LCSW

    3 months ago

    Fort Lee, United States Senior Care Therapy Full time

    Job DescriptionLicensed Clinical Social Worker LCSW What We Offer:   No Admin Tasks! No cancellations! No no-shows!  Flexible Daytime Hours We offer our clinicians with the support and resources they need to succeed!  401(k) Plan for FT or PT employees  Full Time offers Excellent Health, Vision, and Dental Insurance Benefits   Full Time offers...

  • Senior Director of Clinical Operations

    3 weeks ago

    Fort Lee, New Jersey, United States JAG Physical Therapy Full time

    At JAG Physical Therapy, we're seeking a Senior Director of Clinical Operations to lead our team in delivering exceptional patient care and driving business growth. This is a unique opportunity to join a forward-thinking company that prioritizes innovation, teamwork, and customer satisfaction.About UsJAG Physical Therapy is a leading provider of outpatient...

  • Senior Clinical Trial Nurse Specialist

    7 days ago

    Fort Lauderdale, Florida, United States Broward Health Full time

    Senior Research Nurse PositionWe are seeking a highly skilled Senior Research Nurse to join our team at Broward Health. In this critical role, you will be responsible for coordinating research activities, ensuring compliance with regulatory agencies, and providing support to research clients and their families.Duties:Coordinate research studies, ensuring...

  • Medical Oncologist

    3 weeks ago

    Fort Lauderdale, Florida, United States Cleveland Clinic Foundation Full time

    About the RoleCleveland Clinic Florida's Cancer Institute is seeking an accomplished Medical Oncologist with expertise in clinical trials to join our esteemed team at the Maroone Cancer Center in Weston. This full-time position offers a unique opportunity to build a thriving clinical practice and research program while collaborating with multidisciplinary...

  • Senior Clinical Director

    3 weeks ago

    Fort Lee, New Jersey, United States JAG Physical Therapy Full time

    Lead Healthcare Professional OpportunityJAG Physical Therapy, a leading provider of comprehensive outpatient physical therapy services, is seeking an experienced and results-driven Senior Clinical Director to oversee our operations and drive clinical excellence.Key Responsibilities:Oversee the operational and administrative functions of multiple clinics,...

  • Clinical Trial Participant

    3 weeks ago

    Fort Worth, Texas, United States Good Lab Full time

    At Good Lab, we are seeking participants for our clinical trials to test new treatments and medications for various conditions.This is an excellent opportunity for individuals to earn a significant income, sometimes from the comfort of their own home. Participating in clinical trials can be a highly rewarding experience, offering access to cutting-edge...

  • Senior Clinical Research Monitor, Midwest

    2 weeks ago

    Fort Wayne, IN, United States Edwards Lifesciences Full time

    Edwards Lifesciences Senior Clinical Research Monitor, Midwest Field, Nebraska Apply Now Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll...