Job Description:

　　Global Trial oversight of 2 studies within Early Clinical Development.

　　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

　　Managing Phase I - IIb global clinical trials (start up through closure)

　　Management of vendors and CROs

　　CTMS & TMF System - Veeva Vault - supervising setup and maintenance of study teams

　　Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results

　　Start Up:

　　Managing feasibility assessment to select relevant regions and countries for the study

　　Conducting site evaluation and selection

　　Leading investigator meeting preparation and execution

　　Monitoring progress for site activation and monitoring visits and acts on any deviations from plan

　　Managing development and implementation of patient recruitment and patient retention strategies

　　Maintenance:

　　Monitoring data entry and query resolution and taking action on any divergence from agreed metrics

　　Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation

　　Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites

　　Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required

　　Close out:

　　Supervising study close-out activities and contributing to clinical study report writing and reviewAdditional Skills & Qualifications:

　　Bachelor's Degree

　　7+ years of experience LEADING GLOBAL Clinical trials within Pharma Industry

　　2+ years of experience within Early Development (Phase I-IIb) - leading studies

　　5+ years of experience managing and overseeing CRO's and vendors

　　Looking for someone who shows a lot of drive and energy and can handle large workload, attention to detail very important

　　Experience Level:

　　Expert 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.