Current jobs related to Senior Clinical Trial Associate - Bedford - Progenics Pharmaceutical Inc
-
Global Clinical Trials Manager
2 days ago
Bedford, Massachusetts, United States Apex Systems Full timeJob OverviewThe Global Clinical Trials Manager oversees the Clinical Trial Agreement process and manages Contract Research Organizations (CROs) globally to ensure timely and accurate contract execution.Key ResponsibilitiesContract Facilitation: Facilitates efficient site budgeting and contracting for global clinical trials with CRO and study team...
-
Clinical Trial Operations Specialist
1 week ago
New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc is seeking a dedicated and detail-oriented professional to fill the role of Support Specialist for the Investigator Sponsored Trial program. This position is essential in delivering operational assistance across various functional domains associated with clinical trials, while ensuring adherence to regulatory and...
-
Clinical Trial Operations Specialist
1 week ago
New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc is in search of a dedicated and meticulous professional to fulfill the role of Support Specialist for the Investigator Sponsored Trial program. This position entails delivering operational assistance across various functional domains associated with clinical trials, while ensuring adherence to regulatory and financial...
-
Clinical Trial Operations Specialist
5 days ago
New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc is in search of a dedicated and meticulous professional to fulfill the role of Support Specialist for the Investigator Sponsored Trial program. This position entails delivering operational assistance across various functional domains pertinent to clinical trials, while ensuring adherence to regulatory and financial...
-
Clinical Trials Supervisor
5 days ago
New Bedford, Massachusetts, United States Genabio Diagnostics Full timePosition OverviewThe Clinical Research Manager is responsible for overseeing and executing clinical monitoring and site management activities in alignment with ICH Good Clinical Practices, FDA regulations, ISO standards, local laws, and Genabio Diagnostics' standard operating procedures (SOPs). This role emphasizes the development and maintenance of strong...
-
Clinical Trials Supervisor
1 week ago
New Bedford, Massachusetts, United States Genabio Diagnostics Full timePosition OverviewThe Clinical Research Manager is responsible for overseeing and executing clinical monitoring and site management in compliance with ICH Good Clinical Practices, FDA regulations, ISO standards, local laws, and Genabio Diagnostics' standard operating procedures (SOPs). This role is pivotal in fostering collaborative relationships with...
-
Clinical Trials Supervisor
5 days ago
New Bedford, Massachusetts, United States Genabio Diagnostics Full timePosition OverviewThe Clinical Research Manager is responsible for overseeing and executing clinical monitoring and site management in alignment with ICH Good Clinical Practices, FDA regulations, ISO standards, local laws, and Genabio Diagnostics' standard operating procedures (SOPs). This role emphasizes the development and maintenance of strong partnerships...
-
Clinical Trials Supervisor
1 week ago
New Bedford, Massachusetts, United States Genabio Diagnostics Full timePosition OverviewThe Clinical Research Manager is responsible for overseeing and executing clinical monitoring and site management in alignment with ICH Good Clinical Practices, FDA regulations, ISO standards, local laws, and Genabio Diagnostics' standard operating procedures (SOPs). This role is pivotal in fostering collaborative relationships with...
-
Clinical Trials Oversight Manager
5 days ago
New Bedford, Massachusetts, United States Genabio Diagnostics Full timePosition OverviewThe Clinical Research Manager is responsible for overseeing and executing clinical monitoring and site management in alignment with ICH Good Clinical Practices, FDA regulations, ISO standards, local laws, and Genabio Diagnostics' standard operating procedures (SOPs). This role is pivotal in fostering collaborative relationships with...
-
Bedford, United States Obsidian Therapeutics Full timeAssociate/Senior Associate Scientist, Cell Therapy Process Development (Contract) Bedford, MA About Us… Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply...
-
Bedford, United States Obsidian Therapeutics Full timeAssociate/Senior Associate Scientist, Cell Therapy Process Development (Contract) Bedford, MA About Us… Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply...
-
Bedford, United States MannKind Full timeAbout MannKind MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases...
-
Associate Director Clinical Science
2 weeks ago
Bedford, United States Progenics Pharmaceutical Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Associate Director, Clinical Operations
3 months ago
Bedford, United States Progenics Pharmaceutical Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Associate Director, Clinical Operations
3 days ago
Bedford, United States Progenics Pharmaceutical Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Senior Medical Director, Clinical Research
2 months ago
Bedford, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Senior Program Manager
1 month ago
Bedford, United States Ocular Therapeutix Full timeOcular Therapeutix is seeking a highly motivated Senior Program Manager/Associate Director to join its Program Management team, with a focus on clinical and strategic alliance programs. This individual will lead core/program and sub-team initiatives, ensuring alignment with corporate objectives.The Senior Project Manager/Associate Director will manage...
-
Bedford, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in Billerica and in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
-
New Bedford, Massachusetts, United States Obsidian Therapeutics Full timeAssociate/Senior Associate Scientist, Cell Therapy Process Development (Contract)Bedford, MAAbout Us...Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian's programs apply our...
-
New Bedford, Massachusetts, United States Obsidian Therapeutics Full timeAssociate/Senior Associate Scientist, Cell Therapy Process Development (Contract)Bedford, MAAbout Us...Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian's programs apply our...
Senior Clinical Trial Associate
3 months ago
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of Role
The Sr. Clinical Trial Associate (Sr CTA), Clinical Operations is responsible for supporting the operational aspects of multiple studies across all stages of a trial (planning, start-up, execution, data analysis, reporting and closure). Responsibilities include generation of progress tracking reports, trial specific system set-up and access management, system data entry, meeting arrangement / minute capture, document management, and investigator meeting set-up and coordination. The Sr. CTA, as a key member of the study team is expected to provide the needed support to achieve operational deliverables.
Key Responsibilities / Essential Functions
- Participate in team meetings and prepare meeting agendas and minutes.
- Capture meeting action items and track activity status to closure.
- Develop, setup, and maintain study tracking tools for assigned trials to monitor study progress
- Prepare and maintain study progress data as appropriate (e.g., Key Performance Indicators), and prepare study progress reports as necessary
- Track study-related invoices and payments, and other financial information as needed
- Assist in the creation of study materials including study documents, site and patient facing materials, and presentations
- Contribute to the development and/or review of select study plans
- Distribute trial-related materials to sites and/or study team members
- Manage clinical study documents including reviews for completion, accuracy, and expiration
- Coordinate the collection and review of essential documents to authorize initial investigational product shipment and site activation
- Conduct periodic quality assessments of a vendor managed Trial Master File for outsourced studies
- Support the maintenance of the Trial Master File for sponsor-generated documents, and assist in quality assessments as appropriate
- Participate in CRF development and edit check testing
- Participate in user acceptance testing of study systems
- Participate in functional, cross-functional, and organizational initiatives
- Participate in CRO and clinical vendor oversight
- Perform other activities as assigned
Basic Qualifications
- Education: Bachelor’s degree in science or related field
- Experience: Clinical research experience in industry (sponsor or CRO) is required.
- Preferred: CCRP training / certification
Other Requirements
- General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines and applicable regulatory regulations
- Advanced knowledge of clinical study processes
- Basic understanding of the Trial Master File reference model and the ability to navigate an eTMF
- Highly proficient in MS Office applications
- Well organized and detail oriented with strong written and verbal communication skills
- Effective time management and organizational skills
- Significant attention to detail
- Highly effective interpersonal skills
Core Values:
The ideal candidate will embody Lantheus core values:
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone’s health is in our hands
- Own the solution and make it happen
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
