Provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas
Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution
Projects, allocates and prioritizes DM resources within the assigned therapeutic projects
Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality results and within the budget
Mentors junior data managers for skills advancement
Leads and performs clinical data management tasks for studies if required
Ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP’s and work instructions in compliance with applicable regulations
Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects
Designs and modifies CRF

Requirements

Bachelor’s degree in mathematics, Science or a related field
at least 8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry
Previous oncology and/or ophthalmology experience a plus
Previous managerial experience is preferred
directed and comfortable working in teams with the ability to work and operate independently within a tight time line environment
High degree of creativity, latitude and attention to detail required
Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines
Strong communication, leadership and business development skills required
Proficient with appropriate EDC applications and Microsoft Office applications
Software proficiency with CDMS required
Experience with JMP and SAS a plus

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementEDC applicationsCDMSJMPSASdata validationdatabase developmentCRF designproject documentationregulatory compliance

Soft Skills

leadershipcommunicationmentoringteamworkindependencecreativityattention to detailproblem-solvingresource allocationproject planning