eCOA Manager, Clinical Assessment Technologies - US - Remote

Worldwide Clinical Trials

6d • Remote

About The Position

The Clinical Systems Department plays an essential role for the entire organization by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well-maintained throughout the studies’ lifecycle. The department works closely with industry specific systems such as: IRT, RTSM, EDC, RBQM Opra, ClinSpark, eTMF and CTMS. The department has various roles including client-facing Project Managers, System and Software Designers, and Implementation and Validation specialists. Each of these areas provides mentorship and training. In working with a variety of systems, the department has a proven record of success for promotions and growth internally.

Requirements

• Highly organized, detail- and service-oriented with excellent problem-solving skills
• Excellent project management skills, planning, managing, monitoring, scheduling, and critiquing skills
• Excellent at meeting timelines consistently and being able to effectively work under pressure
• Strong writing and verbal communication skills in order to clearly and concisely present information
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Strong ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment
• Bachelor’s degree, in Life Science preferred
• Minimum two years of experience working in eCOA and clinical trials
• Minimum two years of experience in project management
• The individual must demonstrate a strong ability to lead, understand policies and procedures, financial and leadership principles, possesses excellent time management and project management skills and communicate effectively.
• Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials
• Knowledge of SOPs and ICH/GCP/regulatory guidelines

Responsibilities

• Serve as main contact for the eCOA vendor, Sponsor, and Worldwide study team members
• Manage vendor deliverables and timelines, as they relate to study assessments
• Negotiate with eCOA vendor and sponsor regarding eCOA scope of work (SOW)
• Review and identify study trends and proactively work with eCOA vendor and study team to address study specific requirements
• Conduct risk assessments to study due to vendor deliverable delays, availability of materials, equipment, and translations and related concerns
• Responsible for reviewing and communicating with vendor regarding system change control, closeout, and database lock activities

Benefits

• We believe everyone plays an important role in making a world of difference for patients and their caregivers.
• From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed.
• We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.
• We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level