Job Information
Actalent Senior Clinical Trial Manager in Waltham, Massachusetts
This position is hybrid in Waltham, Massachusetts. Oncology and/or cell therapy experience is required.
Responsibilities:
Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trial
Lead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study team
In conjunction with the legal team, facilitate the development of clinical trial agreements and other relevant documents
Coordinate and lead study team meetings and update timelines and milestones as needed
Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs
Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing
Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors
Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies
Additional Skills & Qualifications:
BS/BA in scientific or healthcare discipline
4-7 years’ experience in clinical trial management at a CRO, pharmaceutical/biotechnology company
Knowledge of GCP guidelines and demonstrated experience supporting clinical trials
Early phase clinical trial experience is a plus
Oncology / cell therapy experience
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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