2,123 Clinical Trial Manager jobs in the United States

Job Description

CLINICAL TRIAL MANAGER

Location: Menlo Park, CA onsite

About Summit:

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting .

Overview of Role:

The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

• Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met

• Initiates and builds solid professional relationships with key opinion leaders and clinical site staff

• Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time

• Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data

• Proactive identification and management of study related risks

• Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements

• Responsible for reviewing and managing study related plans, processes including

• Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring

• Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met

• Reviews and approves essential document packages to enable timely site activations

• Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report

• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates

• Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary

• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study

• Perform periodic QC of the TMF

• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs

• Ensures the study is “inspection ready” always

• Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred

• 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization

• Prior phase II and III experience required

• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process

• Experience with budget forecasting and management

• Experience with clinical studies in oncology

• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)

• Proven proficiency in overseeing large complex studies being managed in house and by a CRO

• Demonstrated ability to lead teams and work in a fast-paced team environment

• Experienced and enjoys building relationships with KOLs and site personnel

• Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues

• Demonstrated ability to build and deliver on patient enrollment strategies

• Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives

• Demonstrated ability to comprehend complex scientific concepts and data

• Proficient in reviewing and assessing clinical data

• Possesses excellent planning, time management & coordination skills

• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs

• Experience in working in a small organization

• Excellent written and oral communication skills

The pay range for this role is $134,500 - $158,000 per year. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description

Description:

Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardiometabolic disease targets. Our therapies have the potential to complement existing therapies and serve as transformative treatment options for significant patient populations living with cardiometabolic diseases.

Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of life science investors including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures. The company’s lead program is in Phase 2 clinical development (MAR001) and a second program is progressing towards clinical development in a rare cardiometabolic disease. Marea is a fast-growing company looking for extraordinary individuals to join our team who want to make a difference in the lives of millions of people living with cardiometabolic diseases. The company is led by a dynamic team of scientists and company builders with deep knowledge and experience in cardio-endocrine diseases, human genetics, and adipocyte biology.

At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.

SUMMARY

The Clinical Trial Manager will provide operational and technical expertise to help plan and execute Marea sponsored clinical trials in alignment with corporate goals and objectives. This individual will initially be asked to manage key operational management components of a global phase 2 trial for Marea’s leading cardiometabolic program under the supervision of the Marea Study Lead and may be asked to provide back-up support for other trials as needed. This individual will eventually take on a Study Lead role for new trials downstream. The Clinical Trial Manager will partner with the Clinical Operations Team to build and develop fit-for-purpose internal infrastructure and processes to support Marea-sponsored trials.

This is a full-time position, with a strong preference for candidates that can work on-site at least three days per week in the San Francisco-based office.

Study Management

· Support global phase 2 Study Lead to ensure that all key trial milestones and activities are completed on-time and within budget, by managing key components of the trial.

· Support the development and maintenance of key trial documents such as protocols, ICFs, study plans, etc.

· Lead critical site and trial management activities such as ICF review, site activations, tracking monitoring visit scheduling, review monitoring visit reports.

· Generate and maintain internal trial management trackers and reports.

CRO & Vendor Oversight

· Participate in routine CRO meetings to support management of clinical trial(s) to support study start-up, interim, and close-out activities.

· Manage ancillary vendors supporting clinical trials; lead routine meetings with ancillary vendors.

· Track timely scheduling of monitoring visits; track and review timely completion and monitoring visit reports.

· Conduct co-monitoring visits with CRO CRAs as needed.

· Oversee eTMF activities at CRO, including final reconciliation of eTMF prior to transfer to Marea at end of trial.

Clinical Trial Quality & Compliance

· Partners with Study Lead to ensure Marea sponsored clinical trials are conducted in accordance with ICH GCPs; contribute to any inspection readiness activities as appropriate for each phase of clinical development.

· Partners with internal and external data management lead to ensure high quality and timely data.

· Track and identify any trends or signals while performing routine review of study data listings, trackers, or monitoring visit reports.

Department Support

· Lead department process improvement initiatives and SOP development as needed.

· Support maintenance of internal organization and storage of study documents and files.

· Participate in the interview process for similar or junior roles in Clinical Operations.

Mentor and support junior staff as needed.

QUALIFICATIONS

· Bachelor’s degree required in life science or health related field; advanced degree preferred.

· At least 5 years of clinical trials management experience at a biopharma sponsor or CRO.

· Experience in cardiometabolic or other common disease drug development experience, with strong grasp of fundamentals of clinical trial design and execution as well as the overall clinical development process.

· Proven track record of working on ph 1 trials to global ph 2/3 trials.

· Working knowledge of ICH guidelines, FDA/EMA regulations.

· Experience with managing CROs and clinical trial vendors in a hybrid insource / outsource model, including tracking vendor performance management and managing vendor budgets and invoices.

· Requires project management skills, strong organization, and time management skills along with study leadership abilities

· Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks or assigned projects

· Work with limited supervision both independently and as part of a team with the ability to handle competing priorities

· Flexible and willing to roll up your sleeves and be hands on in a dynamic start-up environment, taking on a wide range of clinical operations tasks as needed.

· Travel domestically and internationally as required to carry out responsibilities

· Ability to read and understand scientific literature

· Must have excellent interpersonal, written, and verbal communication skills

· Strong computer experience and demonstrated proficiency in MS Office (Outlook, G-Suite, MS Word, Excel, PowerPoint)

· Demonstrated leadership skills and equally able to be a strong team player.

· Ability to travel up to 30% as needed.

Job Description

Location: Menlo Park, CA, Princeton NJ or Miami FL. onsite 4 days per week

About Summit:

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting .

Overview of Role:

The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

• Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
• Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
• Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
• Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
• Proactive identification and management of study related risks
• Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
• Responsible for reviewing and managing study related plans, processes including
• Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
• Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
• Reviews and approves essential document packages to enable timely site activations
• Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
• Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
• Perform periodic QC of the TMF
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensures the study is “inspection ready” always
• Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
• Minimum of 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Experience with budget forecasting and management
• Experience with clinical studies in oncology
• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
• Proven proficiency in overseeing large complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced team environment
• Experienced and enjoys building relationships with KOLs and site personnel
• Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
• Demonstrated ability to build and deliver on patient enrollment strategies
• Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to comprehend complex scientific concepts and data
• Proficient in reviewing and assessing clinical data
• Possesses excellent planning, time management & coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Experience in working in a small organization
• Excellent written and oral communication skills

The pay range for this role is $134,500 - $158,000 per year. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Medpace is a leading CRO for Biotech companies and we are currently seeking candidates with
PhDs and/or Post-Doctoral Research experience
within
Metabolic research
for a full-time,
office-based
Associate Clinical Trial Manager (aCTM) to join our Clinical Trial Management team. The aCTM will be a part of the Clinical Trial Management team and support Project Coordinators and Clinical Trial Managers in performance of project management activities. Candidate must have a desire to transfer and apply analytical and academic skills in clinical project administration and management.

This is a fantastic opportunity for recent PhD graduates to enter the industry, receive solid foundational training, work in an international environment, and develop their career in the research and development of cutting-edge therapeutics. Candidates should expect to have an intensive training period and show the desire and aptitude for an accelerated career path into Clinical Trial Management (CTM).

Responsibilities

• Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager;
• Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy;
• Compile and maintain project-specific status reports within the clinical trial management system;
• Interact with the internal project team, Sponsor, study sites, and third-party vendors;
• Provide oversight and quality control of our internal regulatory filing system;
• Provide oversight and management of study supplies;
• Create and maintain project timelines; and
• Coordinate project meetings and produce quality minutes.

Qualifications

• PhD in Life Sciences;
• Fluency in English with solid presentation skills;
• Ability to work in a fast-paced dynamic industry within an international team;
• Prior experience within the CRO or pharmaceutical industry not required but will be advantageous; and
• Excellent computer (word-processing, databases, Excel, Windows), organizational, and communication skills.

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

• Cincinnati Campus Overview
• Flexible work environment
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs

Awards

• Named a Top Workplace in 2024 by The Cincinnati Enquirer
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Job Responsibilities :

• Manage assigned clinical studies within a designated budget and timeline.
• Conduct CRO, Vendor and site assessment and selection; negotiating budget and contracts.
• Conduct site qualification, initiation, interim monitoring and close-out visits. Collecting and reviewing trial master documentation. Document results of visits in monitoring reports for review and finalization.
• Facilitate IRB submissions and renewals when needed.
• Oversee clinical sites, central lab, and other third parties to ensure issues are resolved timely. Motivating investigational sites to close queries and action items.
• Develop or review clinical project plans and clinical trial documentation.
• Collaborate with Regulatory to prepare FDA pre-submission and submission packages.
• Oversee the development of a clinical study database by third party, review and summarize clinical data, perform data analysis and reports.
• Oversee all study team members training to ensure accurate execution of clinical protocols.

Qualifications:

• Bachelors degree (or higher) in science or health-related discipline
• Minimum 3 years of clinical research experience for medical device and IVD products, specialty in respiratory diseases or STD is preferred
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
• Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
• Ability and willingness to travel ~10-15% of the time