FSP Clinical Data Team Lead II

at  Thermo Fisher Scientific

Texas, Texas, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate03 Dec, 2024Not Specified04 Sep, 20245 year(s) or aboveCommunication Skills,Clinical Data,Grammar,Confidentiality,Interpersonal Skills,Timelines,Regulatory GuidelinesNoNo
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Description:

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

Responsibilities:

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.


REQUIREMENT SUMMARY

Min:5.0Max:10.0 year(s)

Information Technology/IT

IT Software - Other

Software Engineering

Graduate

Proficient

1

Texas, USA