Clinical Trial Manager, Oncology

ACIST Medical Systems, Inc.; Needham (MA); Hybrid; USD 125,000 - 135,000; Full time

Job summary

Blue Earth Diagnostics in Needham, MA is seeking a Clinical Trial Manager to oversee all aspects of BED-sponsored trials in line with GCP, regulations, and SOPs. The role features a hybrid schedule with onsite work three days a week at 197 First Avenue.

You will lead cross-functional teams, manage timelines and budgets, work with CROs and sites, and ensure risk mitigation and contract alignment. Oncology and radiopharmaceutical trial experience are valuable.

Qualifications

• Must have a life science or nursing degree or a similar qualification.
• Minimum 3 years of trial management experience at trial management level on international clinical trials.
• Oncology clinical trial experience and radiopharmaceutical trial management desirable.
• Knowledge of ICH GCP and international regulatory guidelines is a bonus.
• Excellent decision-making, facilitation, communication and organizational skills.
• Ability to work with cross-functional and matrixed teams and manage vendors.

Responsibilities

• Plan, implement, monitor and report on progress against project plans and revise/update as necessary.
• Lead the study team, managing timelines, budgets, resources, vendors and strategy.
• Coordinate with internal teams and external partners to manage trial timelines and budget.
• Maintain tracking and reports on trial progress against timelines and budget.
• Act as primary contact with CROs, sites and vendors for assigned trials.
• Understand delivery strategy and budgeting to manage vendors.
• Ensure robust risk mitigation and escalate issues to stakeholders.
• Forecast changes in SOW and budget for long-term planning.
• Perform other duties as determined by business needs.

Skills

Trial management

Clinical operations

Budget management

Cross-functional leadership

Vendor management

ICH GCP knowledge

Education

Life science or nursing degree

Job description

About Blue Earth Diagnostics

Blue Earth Diagnostics, a subsidiary of Bracco Imaging, is a global company advancing precision molecular imaging to support timely decisions and better patient outcomes. Founded in 2014, we work closely with clinicians and collaborators, bringing deep expertise to the development and delivery of positron emission tomography (PET) radiopharmaceuticals. Our growing portfolio helps uncover disease sooner and guide treatment choices across multiple disease states, including oncology and cardiology. Backed by a dedicated team, we deliver clear answers when decisions matter most. For more information, please visit: www.blueearthdiagnostics.com .

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About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is an established molecular imaging company on a growth trajectory to provide innovative, well differentiated diagnostics solutions, informing patients and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by its management expertise and agility, supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer, with an expanding pipeline in disease states. Blue Earth Diagnostics’ strategy is to apply its knowledge and expertise to developing promising cancer radiopharmaceuticals for 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 credibility 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.

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 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, 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.

The salary range for this position is $125,000 - $135,000.

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.