**This role is HYBRID in Cambridge, MA and would require this individual to go on-site 2-3 days a week**

Primary Responsibilities

• Independently lead / manage clinical data management activities

• Manage the communications with Sponsor

• 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 10 years of data management experience in CRO/pharma/biotech setting

• At least 8 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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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

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

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.