Primary Responsibilities

　　• Independently lead / manage clinical data management activities

　　• Manage the performance of Clinical Research Organizations (CRO) performing data management activities

　　• Oversee/contribute to Case Report Form development and database development and modifications

　　• Responsible for all DM activities from start-up, conduct, and closeout

　　• Lead/drive project deliverables and timelines and development teams and provide input into assay development, CRO selection and CRO management

　　• Review and approve clinical trial documentation, such as protocol, timelines, Data Management Plan, Case Report Form Completion Guidelines, and other documentation

　　• Draft, review and finalize internal data management documentation

　　• Participate/lead Sponsor Acceptance Testing

　　• Perform data cleaning and external vendor data reconciliation

　　• Collaborate/work with Biostatisticians, Statistical Programmers, Medical Monitors and Clinical Operation Trial Lead, Pharmacovigilance, Regulatory Affairs, and other line functions/departments on clinical trials

　　• Participate/lead in data management and cross-functional project clinical trial meetings

　　• Develop and communicate requirements, timelines, strategy, and deliverables both internally and externally to ensure achievements are met

　　• Manage/perform other duties as needed

　　Requirements:

　　• B.S. in a scientific field with 5-7 years of data management experience in CRO/pharma/biotech setting

　　• At least 3+ years as a lead Clinical Data Manager

　　• Proficient in clinical data collection, cleaning, and analysis for clinical trials

　　• Experience in rare disease required; neuromuscular and / or pediatrics experience preferred

　　• Experience working in an outsourced Data Management model

　　• Experience with EDC systems is required; Medidata Rave experience a plus

　　• Solid understanding of ICH GCP as well as general knowledge of industry practices and standards (CDASH, SDTM)

　　• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11

　　• Interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills

　　• Ability to self-motivate and lead with confidence is critical

　　• Excellent organizational and time management skills, sense of urgency

　　• Strong analytical and problem-solving skills

　　• Project Management skills

　　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.