Clinical Trial Manager - Blue Earth Diagnostics Inc at Bracco Medical Technologies

Needham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

135000.0

Posted On

22 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Oncology, Radiopharmaceuticals, GCP, Regulatory Requirements, Decision-Making, Communication, Organizational Skills, Vendor Management, Risk Mitigation, Monitoring, Cross-Functional Collaboration, Budget Management, Resource Management, Project Planning, Team Leadership

Industry

Pharmaceutical Manufacturing

Description

About Blue Earth Diagnostics: Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging. - Job Purpose The Clinical Trial Manager (CTM), is responsible for the management of all aspects of Clinical Trial activities for their assigned Trial(s). This includes the efficient execution of BED sponsored clinical trials in overall compliance with Good Clinical Practice (GCP), Country Regulations and company Standard Operating Procedures (SOP’s), according to time and budget. This position will operate on a hybrid work schedule, with the expectation of working onsite 3 days a week in our office located at 197 First Avenue, Needham, MA. Main Responsibilities, Activities, Duties and Tasks • In accordance with BED SOPs: plan, implement, monitor and report on progress against project plans and revise/update as necessary throughout the lifetime of the study. • Lead the combined study team ensuring effective cross-functional teamwork, while managing trial timelines, budgets, resources, vendors and strategy. • Work directly with internal teams and external partners to create and proactively manage trial timelines, budgets, resources, vendors and strategy. • Maintains tracking and provides reports on clinical trial progress against timelines and budget. Monitor trial assumptions, schedule and costs to ensure all remain on track with the executed contract(s). • Act as the primary contact point with CROs, clinical sites and vendors for assigned trial(s). • Understand the trial delivery strategy, costing assumptions and resulting budget for assigned trial(s) in order to manage vendors. • Ensure that a robust risk mitigation strategy is in-place, regularly monitored for each study, and any issues are escalated as needed to appropriate stakeholders. • Track and forecast changes in SOW and associated budget including forecasting annual and 5 years planning /spend. • Other duties as determined by business needs Education/Qualifications • Must have a life science or nursing degree or a similar qualification. Professional Experience, Knowledge, & Technical Skills • Must have at least 3 years of previous trial management experience at trial management level on international clinical trials in pharmaceutical and/or CRO industries. • Oncology clinical trial experience desirable. • Experience with Radiopharmaceutical clinical trial management highly desirable but not mandatory. • Knowledge of ICH GCP, international regulatory requirements & guidelines for the conduct of clinical development programs is also a bonus. • Excellent decision-making, facilitation, communication and organizational skills. • Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors. Ability to influence and build relationships/earn credi-bility quickly across broad global constituencies with competing priorities. • Must be able to understand, interpret, and explain protocol requirements to others in a clear and concise manner. • Must have prior monitoring experience as co-monitoring may be required. • Experience and skilled with cross-functional and highly matrixed organizations. • Demonstrated ability to handle multiple competing priorities, utilize resources effectively and adapt flexibly to changing priorities. • Effective computer skills with good working knowledge of a range of computer programs. • Team player. How to Apply: Please submit your CV and a cover letter outlining: • Why this role appeals to you. • How your background and skills are suited to this role. Why Blue Earth Diagnostics? We are seeking motivated individuals with drive and determination to succeed in an innovative and respectful team environment. Our employees are empowered to achieve great things and thrive in our exceptionally co-operative culture. As a dynamic company experiencing rapid growth, BED prides itself on providing a clear focus and incentives to achieve our business-critical objec-tives. We aim to have fun and celebrate each milestone along the way. If you are seeking a job where you have a clear impact on business success, are working with talented and collaborative colleagues daily, and are doing something great for human healthcare, then this job is for you. Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, generous paid holidays, and promote work/life harmony. Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law. Annual Salary: $120,000.00-$135,000.00 Why Blue Earth Diagnostics? We are seeking motivated individuals with drive and determination to succeed in an innovative and respectful team environment. Our employees are empowered to achieve great things and thrive in our exceptionally co-operative culture. As a young and dynamic company experiencing rapid growth, Blue Earth Diagnostics prides itself on providing a clear focus and incentives to achieve our business-critical objectives. We aim to have fun and celebrate each milestone along the way. If you are seeking a job where you have a clear impact on business success, are working with talented and collaborative colleagues daily, and are doing something great for human healthcare, then this job is for you. Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, work/life harmony, and generous paid holidays. Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law. Improve people’s lives by shaping the future of prevention and precision imaging. This is our purpose. Our work impacts millions of people all over the world. Not least the more than 4,000 Bracco colleagues who work to improve lives every single day. That is quite a responsibility and something we proudly embrace. We are the Bracco Group!

Responsibilities

The Clinical Trial Manager is responsible for managing all aspects of clinical trial activities, ensuring compliance with regulations and company SOPs. This includes planning, implementing, monitoring, and reporting on trial progress while managing timelines, budgets, and resources.