IMMEDIATE SENIOR CLINICAL STUDY MANAGEMENT OPPORTUNITY WITH LEADING BIOPHARMA!!

　　This opportunity is with a multi-billion dollar company who is currently leading the industry with 9 marketed drugs and a robust pipeline containing multiple trials in phases I-III. In addition, 100% of their drug candidates are invented and developed in house ! This company has great culture and is rapidly growing!

　　Summary: The Senior Clinical Study Lead, is responsible for leading global clinical trials from start up through closure (internally sourced studies and studies outsourced to CROs). Direct Management and oversight of third-party vendors and CROs. Experience driving process improvement initiatives. Will be responsible for developing study specific documentation (Case report forms - CRFs, data management plans, monitoring plans, monitoring oversight plans, data review plan, statistical analysis plan, etc. Responsible for leading risk assessments and identifying risk mitigation strategies at the study level. Directly supervising Clinical Trial Management staff, including assigning work, performance management, recruitment, mentoring and professional development.

　　Qualifications:

　　5+ years of Clinical Trial management experience (Pharma/Biotech/CRO)

　　3+ years of GLOBAL experience

　　5+ years of vendor/CRO Oversight experience (Pharma/Biotech/CRO)

　　eTMF Experience (Experience maintaining the eTMF (file, upload, scan, QC all study documents such as 1572, financial disclosures, informed consents, CV’s, etc. as per company SOPs and FDA guidelines), including supporting periodic review of study files for accuracy and completeness.

　　Experience taking meeting minutes/preparing meeting agendas

　　Bachelors Degree minimum

　　Benefits:

　　Medical, Dental, Vision, 401K

　　Paid Time Off

　　Holiday Pay

　　Sick Leave

　　Remote Flexibility (hybrid 2X per week onsite)

　　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.