We are seeking a Clinical Scientist/Manager to join our Clinical group, with a minimum of 3-5 years pharmaceutical industry experience including oncology.

　　The successful candidate must have excellent written and oral communication skills, have a working knowledge of FDA clinical regulatory and compliance requirements, and have experience in clinical trial planning, study conduct, site monitoring, and project management. The focus of this position is to support the planning and assessment of clinical trial data and the preparation of documentation required to support IND, NDA, and BLA applications.

　　Description:

　　Review of clinical data/tables, clinical study reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan.

　　Contribute to the design, and reporting of clinical studies performed by clients or by other CROs

　　Draft written summaries for regulatory submissions including INDs, NDAs, and BLAs.

　　Create and maintain project plans.

　　Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies.

　　Additional Skills & Qualifications:

　　Must have an excellent understanding of oncology clinical data. Ability to conduct detailed review and analyses of clinical data and to generate queries as needed to ensure that we have data that is clean and submission ready. Must be resourceful and have outstanding abilities to synthesize and make connections

　　Assists in the development of portions of key documents for clinical programs

　　Contributes to decision-making and provides well-reasoned, thorough reviews, due diligence and proposals to cross-functional project teams. Engages in team discussions and provides translational sciences support for assigned projects

　　Outstanding communication skills, both oral and written.

　　Minimum level of education: Bachelor's degree

　　Experience Level:

　　Intermediate Level

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.