Current jobs related to Senior Manager, Clinical Trial Management - Waltham - Upstream Bio
-
Clinical Trial Manager
3 weeks ago
Waltham, United States Clinical Dynamix, Inc. Full timeThe Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office...
-
Senior Clinical Trial Manager
2 days ago
Waltham, United States GQR Full timeSenior Clinical Trial Manager – Biopharma Company (MA-based)Overview:A clinical-stage biopharma company dedicated to developing treatments for autoimmune and rare diseases seeks an experienced Senior Clinical Trial Manager. The company focuses on innovative antibody discovery, emphasizing data-driven decisions and thoughtful risk-taking to bring...
-
Senior Clinical Trial Manager
2 weeks ago
Waltham, United States GQR Full timeSenior Clinical Trial Manager – Biopharma Company (MA-based)Overview:A clinical-stage biopharma company dedicated to developing treatments for autoimmune and rare diseases seeks an experienced Senior Clinical Trial Manager. The company focuses on innovative antibody discovery, emphasizing data-driven decisions and thoughtful risk-taking to bring...
-
Senior Clinical Trial Manager
3 weeks ago
Waltham, United States Apellis Full timeJob DescriptionJob DescriptionPosition Summary:The Senior Clinical Trial Manager is responsible for oversight and the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with minimal oversight from the Associate Director/Director, Clinical Operations. The Senior Clinical Trial Manager actively...
-
Senior Biostatistics Manager Clinical Trials
1 week ago
Waltham, Massachusetts, United States Apellis Pharmaceuticals Full timeSenior Biostatistics Manager Clinical Trials at Apellis PharmaceuticalsWe are seeking an experienced Senior Biostatistics Manager Clinical Trials to lead our statistical efforts in clinical trials.About the Role:The ideal candidate will have a strong background in biostatistics and experience managing statistical teams. You will be responsible for developing...
-
GQR | Senior Clinical Trial Manager
2 weeks ago
waltham, United States GQR Full timeSenior Clinical Trial Manager – Biopharma Company (MA-based)Overview:A clinical-stage biopharma company dedicated to developing treatments for autoimmune and rare diseases seeks an experienced Senior Clinical Trial Manager. The company focuses on innovative antibody discovery, emphasizing data-driven decisions and thoughtful risk-taking to bring...
-
Senior Clinical Trial Manager
1 month ago
Waltham, United States ClinLab Staffing Full timeSr Clinical Trial ManagerResponsibilities (including, but not limited to):Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.Supports external vendor...
-
Senior Clinical Trial Manager
3 weeks ago
Waltham, MA, United States Apellis Pharmaceuticals, Inc. Full timePosition Summary: The Senior Clinical Trial Manager is responsible for oversight and the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with minimal oversight from the Associate Director/Director, Clinical Operations. The Senior Clinical Trial Manager actively contributes to and supports an...
-
Clinical Trial Manager
6 months ago
Waltham, United States Royalty Staffing Full time $130,000 - $155,000The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office...
-
Clinical Trial Manager
1 week ago
Waltham, Massachusetts, United States Royalty Staffing Full timeAbout Royalty StaffingOur Company OverviewWe are a dynamic and innovative company, passionate about delivering exceptional staffing solutions to our clients.In this role, you will be part of our Clinical Trials team, which is responsible for managing the execution of clinical studies on schedule and on budget.A Day in the Life of Our Clinical Trials...
-
Senior Clinical Trial Associate
1 month ago
Waltham, United States GQR Full timeSenior Clinical Trial AssociateLocation: Waltham, MA (Hybrid, three days per week in the office)About the Role:This position involves assisting the Clinical Operations team in managing clinical trials, from startup to closeout, ensuring compliance with ICH, GCP, CFR, and SOP standards. Responsibilities include maintaining the Trial Master File, site...
-
Clinical Trials Operations Manager
4 weeks ago
Waltham, Massachusetts, United States ClinLab Staffing Full timeAbout ClinLab StaffingClinLab Staffing is a leading provider of clinical trial management services. We are dedicated to delivering high-quality projects that meet our clients' needs.Job SummaryWe are seeking an experienced Clinical Trials Operations Manager to join our team. This individual will be responsible for managing the day-to-day activities of...
-
Regional Clinical Trial Manager
4 weeks ago
Waltham, United States GQR Full timeLocation: 3x per week in Waltham, MA Description The client is a biotech company that is focused on developing advanced medicines for individuals living with autoimmune and rare diseases. Using expertise in antibody discovery and engineering, they have established a pipeline of unique investigational therapeutic candidates for well-validated targets. The...
-
Regional Clinical Trial Manager
2 days ago
Waltham, United States GQR Full timeLocation: 3x per week in Waltham, MA Description The client is a biotech company that is focused on developing advanced medicines for individuals living with autoimmune and rare diseases. Using expertise in antibody discovery and engineering, they have established a pipeline of unique investigational therapeutic candidates for well-validated targets. The...
-
Clinical Trials Manager Lead
4 weeks ago
Waltham, Massachusetts, United States Royalty Staffing Full timeAbout the RoleAt Royalty Staffing, we are seeking an experienced Clinical Trials Manager Lead to join our team in Waltham, MA. As a key member of our clinical operations team, you will play a crucial role in leading the execution of clinical studies on schedule and on budget.Job DescriptionThe Clinical Trials Manager (CTM) is responsible for delivering...
-
Clinical Trial Management Specialist
4 weeks ago
Waltham, Massachusetts, United States GQR Full timeAbout GQR and the Role:We are seeking a seasoned Clinical Trial Associate to join our team at GQR in Waltham, MA. This hybrid role offers the perfect blend of remote work and collaboration with our clinical operations team.Key Responsibilities:Maintain accurate and up-to-date Trial Master Files (TMFs), ensuring compliance with regulatory...
-
waltham, United States ClinLab Staffing Full timeSr Clinical Trial ManagerResponsibilities (including, but not limited to):Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.Supports external vendor...
-
waltham, United States ClinLab Staffing Full timeSr Clinical Trial ManagerResponsibilities (including, but not limited to):Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.Supports external vendor...
-
Waltham, Massachusetts, United States Lifelancer Full timeUnlock a Rewarding Career in Clinical TrialsIn this pivotal role as Senior Clinical Trial Associate, you will play a crucial part in shaping the future of inflammatory bowel disease (IBD) treatments. Join our dynamic team at Spyre Therapeutics, a clinical-stage biotechnology company dedicated to creating innovative therapies for patients.Competitive Salary...
-
waltham, United States GQR Full timeSenior Clinical Trial AssociateLocation: Waltham, MA (Hybrid, three days per week in the office)About the Role:This position involves assisting the Clinical Operations team in managing clinical trials, from startup to closeout, ensuring compliance with ICH, GCP, CFR, and SOP standards. Responsibilities include maintaining the Trial Master File, site...
Senior Manager, Clinical Trial Management
3 months ago
Position Summary:
Upstream Bio seeks a resourceful, data-driven and integrative thinker for an important role overseeing clinical vendors supporting one or more of our clinical trials. This key role will plan, oversee and drive high quality end-to-end clinical trial vendor delivery in a fully outsourced model to ensure data integration across clinical trial vendor types (such as eDC, eCOA, Lab, Imaging). Additionally, this individual will provide guidance and shared learning throughout planning and implementation, as well as ensure clinical trial vendor deliverables and timelines are met across assigned clinical trials. This position will report to the Head of Clinical Operations.
This position requires a strong ability to synthesize scientific, clinical and business considerations into a cohesive clinical vendor operational and data delivery strategy. This individual will use outstanding cross-functional skills to achieve study and program goals and will develop a solid understanding of the clinical indications being pursued including knowledge of the patient needs, development plan, applicable regulatory guidance as well as the competitive landscape in the therapeutic space. The ideal candidate has clinical trial operations experience and strong project management skills combined with a critical eye for important details.
Excellent written and oral communication skills are required to represent the trials and program to internal and external stakeholders, as is the desire and ability to work in a small, fast-paced, and patient-focused environment. Adaptability to changing study and program needs and challenges and an innovative approach to problem solving will be important characteristics of the successful candidate.
Key Responsibilities:
- Plan and oversee key third party vendor-related aspects of single and multi-center global clinical trials in compliance with GCPs / SOPs and applicable regulations, within approved budgets and timelines and in close collaborations with key stakeholders and Clinical Research Organizations (CROs)
- Contribute to CRO/vendors identification, qualification and selection processes as applicable.
- Provide oversight for relevant vendors-related activities, including contracting, budgeting and documentation
- Partner with the Clinical Operations Lead and CRO Study Management Team lead to ensure effective third party vendor risks identification & mitigation strategies as well as proactively identify & resolve issues
- Drive effective integration of clinical trial data derived from key vendors via vendor strategy setting, implementation within vendor specifications / requirements and ongoing oversight
- Develop and implement clinical oversight plans and perform ongoing risk-based data-driven review pertinent to clinical oversight activities
- Collect and analyze qualitative and quantitative results from quality oversight activities and develop reporting that highlights areas of concern and outlines investigations, action plans, and resolution
- Provide expertise to oversee the end-to-end data delivery integration activities across clinical vendor types (may include eDC, eCOA, Labs, Imaging). This includes providing oversight of operational input into vendor specifications and requirements, as well as data transfer agreements and/or transfer specifications for third party vendors
- Secure agreement with appropriate stakeholders (clinical operations, clinical development, clinical supplies, translational research, quality) to develop strategies across studies
- As applicable, act as Subject Matter Expect for oversight of the electronic trial master file (eTMF) (provided by third party vendor) across trials and vendors
- May be required to perform other activities, as assigned, in support of successful study execution, such as overseeing other areas of clinical trial management, participating in onboarding study team members.
Qualifications:
- Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.
- 6+ years of relevant clinical operations experience, in trial management and/or vendor oversight roles
- Strong knowledge of ICH GCP and global regulatory and compliance requirements for clinical research. Experience with regulatory inspections a plus.
- Strong critical thinking, with ability to understand the big picture as well as the important details that may impact the big picture.
- Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications
- Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing.
About Upstream Bio:
Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.
