Senior Clinical Data Manager - FULLY REMOTE

**Agencies please do not submit any candidates**

About the Role:

Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, set up, maintenance, and close out. Manages the day-to-day data management project activities including, but not limited to timelines, budgets, staff, project scope, reports, and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Managers and Clinical Data Analysts.

#LIRemote

Requirements

• Exceptional working knowledge of clinical trials and the data management role in the clinical trials process
• Excellent organizational and project management skills
• Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
• A minimum of 3 years of staff mentoring and leadership experience
• Outstanding leadership capabilities
• Strong delegation abilities
• Highly effective written and verbal communication skills in English
• Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products
• Desirable skills include: CRF design, MS Project, involvement with a federal submission (either NDA or PMA), programming skills (SAS, PL/SQL), analytical capabilities, medical coding (adverse events and medical therapies)
• Experience in multiple therapeutic areas (TAs) in clinical trials is mandatory including experience in at least two of the following TAs: ophthalmology, oncology, cardiology, central nervous system (CNS), infectious disease, respiratory, endocrinology, gastroenterology

Education or Equivalent Experience

• Master’s degree (preferably in engineering, applied or life science) and at least four (4) years of experience in clinical data management including leading several clinical studies, or
• Bachelor’s degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of five (5) years of experience in clinical trials, or
• Current Certified Clinical Data Manager (CCDM) status and five (5) years of experience in clinical trials.

Benefits

What you can expect from us:

• Competitive wages
• Flexible work schedules
• Fully remote roles
• Variety of therapeutic areas
• Career advancements
• Medical insurance
• HSA with company match
• Dental with 2 coverage options
• Vision
• 401K with company match
• Paid Time off
• Over 10 company holidays
• Life Insurance
• Inclusive and collaborative company culture
• Identity theft protection
• Voluntary accident and critical illness insurance