Clinical Data Team Lead - Remote U.S

Thermo Fisher Scientific•Morrisville, NC

16h•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. It also serves as an interdepartmental and client liaison for study data management activities. The position performs assigned data management activities independently and efficiently, with attention to quality, and may assist with project administration, financial management, forecasting, and business development activities. The role applies project protocol requirements to daily work and directs others in applying them. It develops and maintains data management documentation, reviews deliverables according to documented CDM guidelines, provides study-specific training, monitors metrics, and prepares regular status reports. The lead also mentors junior staff and helps identify resource needs, out-of-scope work, and contract modifications. Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations and occasional domestic and international travel are required. The listed schedule is standard Monday through Friday; the position is remote in the U.S.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Comparable to 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job; prior experience must reflect lead (end-to-end) responsibilities. An appropriate combination of education, training, and/or directly related experience may be considered equivalent in some cases.
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 command of English language and grammar.
Good organizational, analytical, and problem-solving skills, with attention to detail.
Ability to work productively with minimal supervision.
Ability to maintain a high degree of confidentiality with clinical data and client proprietary data.
Strong customer focus and excellent interpersonal skills.
Flexibility and adaptability.
Ability to work 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.

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.
Independently review data management deliverables in accordance with 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 and communicate them to the Project Lead and management; assist with the Contract Modification process.
Mentor junior-level staff on study-associated tasks.
Assist with the administrative and financial management of allocated projects.
Perform assigned data management activities independently and efficiently, with attention to quality.