Clinical Data Associate II - Remote U.S

Location: Remote, North Carolina, USA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as an Associate Clinical Data Team Lead ll – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to act as a senior-level assistant lead data manager for one or more projects, supporting the lead data manager. As an Associate Clinical Data Team Lead ll, you may co-lead or support by performing assigned tasks in study setup, data cleaning, database close-out, and other associated tasks with limited oversight.

What You’ll Do

• Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
• May participates in team and client meetings and supports the lead data manager with risk management on allocated projects.
• Develops and delivers study specific training to junior associates for assigned projects. Mentors junior staff on study specific tasks.
• Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met.
• Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development.
• Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines.
• Performs all assigned data management activities independently and efficiently, with attention to quality.
• Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to project lead
• Monitors study metrics and runs project-specific status reports for management.
• Reviews data management deliverables for allocated projects following documented guidelines.
• Produces project-specific status reports for management, PM and/or clients on a regular basis.

Education and Experience Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail
• Ability to apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
• Ability to work productively and minimal supervision
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Strong customer focus and excellent interpersonal skills
• Proven flexibility and adaptability
• Ability to work in a team environment and independently as needed
• Ability to train and direct junior team members
• Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

Working Conditions and Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.