Massachusetts Veterans Jobs

MUST HAVES:

• Must Have Gene Therapy Trial Management Experience (Minimum 3 years)

• Must have Phase 1, first in human trial management experience

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.

• Triage CRO and clinical site questions.

• 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.

• Train team members and site staff, including vendors, 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.

REQUIREMENTS:

• BS/BA in scientific or healthcare discipline with 4-7 years’ experience in clinical trial management at a CRO, pharmaceutical/biotechnology company

• Experience with complex therapeutic platforms.

• Strong Oncology and Cell Therapy clinical trials.

• Strong computer skills, including Excel, Word, Outlook, and PowerPoint

• Knowledge of GCP guidelines and demonstrated experience supporting clinical trials

• Excellent interpersonal skills and ability to build strong professional relationships internally and externally

• Strong analytical and problem-solving skills

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.