CASY-MSCCN 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:

BA/BS and 3 or more years of experience with direct clinical trial management, including management of vendors and CROs and ex-US trial and oncology experience is a plus

• Experience in biotech/pharma/medical industry preferred

• Working knowledge of GCP, ICH and relevant CFRs is required

• Experience in early-stage clinical development is strongly preferred

• Oncology experience

  About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.