Data Quality Systems Testing Expert

4 weeks ago

india Thermo Fisher Scientific Full time

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.

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.

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