- Leading tasks as assigned by manager with decisiveness and strong judgment.
- Working with internal cross-functional study execution team and external CROs/vendors to ensure timelines are understood.
- Identifying any potential risks and escalating to manager with mitigation solutions.
- Leading document finalization process with both internal and external stakeholders to ensure all comments/feedback are incorporated and ensure proper grammar and formatting.
- Developing clinical study documents including ICF, study plans, and pharmacy manual.
- Ensuring that all clinical data is managed and completed in a timely manner. Developing tracking tools and reports as appropriate to distribute to the study team.
- Preparing and overseeing of TMF and internal files.
- May participate in regulatory audits and inspections as appropriate.
- Hosting internal study meetings, including the development of agenda and minutes.
- Assist with budget forecasting, monitoring the budget against actuals and apprise Management of variances.
- Mentor and/or train junior team members.
- Science or healthcare bachelor's degree required.
- At least 7 years of clinical research experience at a pharmaceutical/biotech or CRO.
- Strong knowledge and understanding of GCP/ICH Guidelines and relevant CFRs for conducting clinical trials.
- Effective communication (written and verbal), adaptability and self-motivation.
- Ability to balance changing priorities.
- Manages direct reports.
- Strong interpersonal, organizational, and multi-tasking skills.
- Excellent attention to detail and problem-solving skills.
- Ability to work effectively work in a team setting.
- Computer proficiency, including Microsoft Office applications. Experience with EDC and CTMS systems a plus.
- Requires domestic and international travel up to 30% of time.
-
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the executi ...
-
Clinical Trial Manager
6 days ago
Staffmark Group Waltham, United StatesGreat long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting ...
-
Clinical Trial Manager
2 weeks ago
BioSpace Waltham, United StatesJob Details · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operati ...
-
Clinical Trial Manager
6 days ago
Dragonfly Therapeutics Waltham, United StatesClinical Trial Manager · Dragonfly Therapeutics seeks a Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development group and who will be responsible for providing trial management support for our cancer immunotherapy programs. This role ...
-
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the execut ...
-
Clinical Trial Manager
2 weeks ago
Dragonfly Therapeutics, Inc. Waltham, United StatesClinical Trial Manager · Dragonfly Therapeutics seeks a Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development group and who will be responsible for providing trial management support for our cancer immunotherapy programs. This role ...
-
Clinical Trial Manager
1 week ago
BioSpace, Inc. Waltham, United StatesJob Details · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Opera ...
-
Viridian Therapeutics Inc. Waltham, United States· At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driv ...
-
Clinical Trial Manager
2 weeks ago
Alkermes Waltham, United StatesJob Description · Position Summary: · Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. · Responsibilities · Clinical project team member: works closely with the Sr. CTM and/or Clinical Pro ...
-
Tscanrx Waltham, United StatesClinical Trial Manager/Senior Clinical Trial Manager (CT30-2) · LOCATION:Waltham, MA · POSITION SUMMARY: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking f ...
-
Clinical Trial Manager
3 weeks ago
Visterra, Inc. Waltham, United States Full timeSummary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operations. The ideal ...
-
Clinical Trial Manager
1 week ago
Visterra Inc. Waltham, United StatesSummary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operations. The ideal ...
-
Clinical Trial Manager
5 days ago
Advantage Technical Waltham, United StatesGreat long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting ...
-
TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Opera ...
-
Clinical Trial Manager
6 days ago
Alkermes Waltham, United StatesPosition Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I‐IV of development. ...
-
Clinical Trial Manager
3 weeks ago
Alkermes Watertown, United StatesJob Description · Position Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. · ResponsibilitiesClinical project team member: works closely with the Sr. CTM and/or Clinical Program Man ...
-
Senior Clinical Trial Manager
3 weeks ago
Planet Pharma Waltham, United StatesImmediate Need for a Senior Clinical Trial Manager in Waltham, MA with a biotech company. This is a full time permanent position. Must be able to work hybrid in Waltham, MA. · Looking for 3+ years of clinical trial management experience at a biotech or pharmaceutical company. · ...
-
Senior Clinical Trial Manager
6 days ago
BioSpace Waltham, United StatesJob Details · Summary · The Senior Clinical Trial Manager is a key member of the clinical operations team and supports the execution and management of clinical trial(s). The Senior Clinical Trial Manager reports to the Associate Director, Clinical Operations. The ideal candidate ...
-
Senior Clinical Trial Manager
1 week ago
Meet Waltham, United StatesSenior Clinical Trial Manager - Oncology OR Gene Therapy experience REQUIRED · Exciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or CTM (based on experience) motivate ...
-
Senior Clinical Trial Manager
1 week ago
Meet Recruitment Waltham, United StatesSenior Clinical Trial Manager - Oncology OR Rare Disease experience REQUIRED · Exciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or AD (based on experience) motivated ...
Senior Clinical Trial Manager - Waltham, United States - Visterra
Description
Job Description
Job DescriptionSalary:Summary
The Senior Clinical Trial Manager is a key member of the clinical operations team and supports the execution and management of clinical trial(s). The Senior Clinical Trial Manager reports to the Associate Director, Clinical Operations. The ideal candidate should have B.S. degree in science or healthcare and a minimum of seven years of clinical research experience; ideally in early phase development.
Responsibilities
Requirements
Company
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.
Visterra is a wholly-owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 115 employees and is in Waltham, Massachusetts.
Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.