Clinical Data Associate II - Remote U.S

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description

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.