Clinical Data Team Lead - Remote U.S

Thermo Fisher Scientific•Raleigh, NC

18h•Remote

About The Position

The Clinical Data Team Lead acts as the lead data manager for one or more projects or supports the lead data manager. The role may lead all data management activities for individual, limited-volume or limited-complexity studies with support from senior team members. The position also serves as an interdepartmental and client liaison for study data management activities. The role performs assigned data management work independently and efficiently, with attention to quality, and may contribute to business development and project administration and financial management.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Comparable to 2 or more years of relevant experience providing the knowledge, skills and abilities to perform the job; prior experience must reflect lead, end-to-end responsibilities.
Ability to apply knowledge and skills in an organized manner while adhering to regulatory guidelines, SOPs and client expectations.
Ability to use interactive computer programs.
Good written and verbal communication skills, with strong English language and grammar; organizational, analytical and problem-solving skills; and attention to detail.
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 both in a team environment and independently as needed.
Ability to train and direct a study team.
Ability to set and meet timelines or recognize and schedule changes in response to project demands.

Nice To Haves

An equivalency combining appropriate education, training and/or directly related experience may be considered sufficient to meet the role requirements.

Responsibilities

Apply relevant components of the project protocol to daily tasks and direct others in applying them.
Liaise with the Project Lead and/or client as required and communicate with management about data management activities within assigned studies.
Develop and maintain data management project documentation files and independently review data management deliverables according to documented CDM guidelines.
Develop and deliver study-specific training for data management project staff.
Produce regular project-specific status reports for management, the Project Lead and/or clients, and monitor study metrics.
Assist with bid preparation and/or represent data management at bid defense meetings when required.
Assist with project-hour forecasting and identification of resource requirements; identify potential out-of-scope activities for the Project Lead and management and assist with the Contract Modification process.
Mentor junior-level staff on study-related tasks.
Assist with administrative and financial management of allocated projects.
Perform assigned data management activities independently and efficiently, with attention to quality.