FSP Clinical Data Team Lead II

at  Thermo Fisher Scientific

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

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.