Work Schedule
Environmental Conditions
Job Description
Summarized Purpose:
Acts as the lead data manager for one or more projects or to provide support to the lead data manager. May lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Acts as an interdepartmental and client liaison for all DM study activities.
Essential Functions:
- Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
- Acts as a liaison to the Project Lead and/or client as required and communicates with management regarding all data management (DM) activities within their studies.
- Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines.
- Develops and delivers study specific training for DM project staff.
- Produces project-specific status reports for management, Project Lead and/or clients on a regular basis. Monitors study metrics.
- May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required.
- Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Lead and management and assists with the Contract Modification process.
- Mentors junior level staff on all associated tasks within a study.
- Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.
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Education & Experience:
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 5+ years)
Knowledge, Skills and Abilities:
- Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations.
- Ability to use interactive computer programs.
- 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 work productively with 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 study team.
- Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands.