Massachusetts Jobs

Description:

Manage contract research organizations (CRO) and other external vendors to support clinical studies and ensure compliance with quality systems

• Independently manage and oversee study activities, including: selection of investigators, study start-up activities including site initiation, study monitoring activities, data collection and close-out activities

• Provide input to both the CRO and internal clinical development plans for the study, and ensure study team adherence to the plans, as needed and appropriate per study needs

• Develop and manage study timelines and project and track study enrollment

• Contribute to the development of study related documents (contracts, ICF(s), protocol(s), IB(s), etc.)

• Prepare clinical study budgets, monitor budgets for variances and approve invoices, as needed

• Address and escalate relevant operational issues to key stakeholders

• Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate appropriately

• Facilitate internal/external meetings with key cross-functional teams

Qualifications:

• 3+ years of trial management experience

• Experience running a full trial for at least 2 studies

• Someone coming from a smaller sized biotech/pharma preferred

• Rare disease preferred

• Strict 3x a week in office

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.