Clinical Data Associate II - Remote U.S

Thermo Fisher Scientific•Wilmington, NC

2d•Remote

About The Position

The Associate Clinical Data Team Lead II acts as a senior-level assistant lead data manager for one or more projects, supporting the lead data manager. The role may co-lead projects or support them by performing assigned study setup, data cleaning, database close-out, and related tasks with limited oversight. The position performs data management activities independently and efficiently while maintaining quality and following documented clinical data management guidelines. The role applies project protocol requirements to daily work and may direct others in applying them. It supports risk management, develops and delivers study-specific training, mentors junior associates, coordinates data cleaning, and helps ensure project quality standards and timelines. The position also contributes to database specifications, database builds, and user acceptance testing; maintains project documentation; reviews deliverables; assists with forecasting hours and resource needs; identifies potential out-of-scope work; and monitors study metrics and prepares regular status reports. Work is performed in an office environment with exposure to electrical office equipment. Occasional driving to site locations and occasional domestic and international travel may be required.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2 or more years; an equivalent combination of appropriate education, training, and/or directly related experience may be considered.
Good written and verbal communication skills, including a strong command of English language and grammar.
Good organizational, analytical, and problem-solving skills and attention to detail.
Ability to apply knowledge and skills in an organized manner while adhering to regulatory guidelines, SOPs, and client expectations.
Ability to work productively with minimal supervision.
Ability to maintain a high degree of confidentiality with clinical and client proprietary data.
Strong customer focus and excellent interpersonal skills.
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 recognize and schedule changes in response to project demands.

Responsibilities

Apply relevant components of project protocols to daily tasks and direct others in applying them.
Participate in team and client meetings as appropriate and support the lead data manager with risk management on allocated projects.
Develop and deliver study-specific training to junior associates and mentor junior staff on study-specific tasks.
Coordinate data cleaning tasks and delegate them to appropriate data management staff to maintain quality standards and meet project timelines.
Perform assigned activities contributing to database specifications, database build, and user acceptance testing during database and edit check development.
Develop and maintain data management project documentation files.
Independently review data management deliverables for allocated projects in accordance with documented CDM guidelines.
Perform assigned data management activities independently and efficiently, with attention to quality.
Assist with forecasting project hours and identifying resource requirements; identify potential out-of-scope activities for the project lead.
Monitor study metrics and run project-specific status reports for management.
Produce regular project-specific status reports for management, project managers, and/or clients.