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Seeking a Senior Clinical Trial Manager to join a growing biotech company with growth opportunity! The Sr. CTM will lead the operational execution of one of our clinical stage programs. The Sr. CTM will lead the implementation of one or more studies and will manage the relationships with our internal study teams as well as close management of external CROs and vendors. This position will report to the Director of Clinical Operations.

Must haves:

• Ability to work hybrid in Massachusetts (flexible)

• Global experience, preferably EU

• Rare disease or immunology therapeutic experience

• Phase II study experience

• Minimum of 5-8 years experience working in a Clinical Trial Manager capacity

Responsibilities:

• Serves as study lead and primary (internal and external) contact for clinical studies

• Leads and manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, US and Ex US regulatory guidelines and operate within established timelines

• Responsible for managing the study budget and reviewing forecasts, accruals and actual spend

• Manages outsourced clinical operations functions, which may include Clinical Research Organizations, contracted investigational supply, data management, biostatistics, etc.

• Generates and presents frequent study status updates and reports to internal team

• Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.

• Oversees and tracks patient recruitment and proactively identifies ways to prevent recruitment delays

• Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones

• Provides study updates accurately and regularly through frequent communication

• Proactively identifies issues and develops problem-solving strategies to ensure delivery of quality data

• Ensuring that study Trial Master File is maintained and up to date and manages TMF audits as needed

• Prepares for and participates in third-party audits and regulatory inspections

• Complies with ICH GCP guidelines, FDA regulations, and company SOPs

Additional Skills & Qualifications:

• Minimum BS/BA from an undergraduate program

• Proficient with MS Office Suite, particularly Word and Excel

• Self-starter who thrives in a collaborative team environment

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.