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ThermoFisher Scientific Senior Manager, Clinical Data Management FSP in Waltham, Massachusetts

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Acts as a lead data manager for one or more projects and a liaison to the Project Lead and /or client as required.

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 an interdepartmental and client liaison for all DM study activities. · Produces project-specific status reports for management, Project Lead and/or clients on a regular basis. · Monitors and analyzes study metrics and escalates per the organization's risk management processes. · May participate in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required. · Assists with project forecasting of hours and identification of resource requirements. · Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process. · Leads, high volume/highly complex studies. · Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget. · Mentors junior level staff on all associated tasks within a study. ·

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). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 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 in both a team environment and independently as needed · Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data · Strong customer focus and excellent interpersonal skills. · Ability to direct and train study team · Ability to act as a study or department expert for DM processes · Ability to support project resourcing and project timeline planning and adherence to timelines Management Role: No management responsibility Working Conditions and Environment: · Work is performed in an office environment with exposure to electrical office equipment. · Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: · Frequently stationary for 6-8 hours per day. · Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. · Frequent mobility required. · Occasional crouching, stooping, bending and twisting of upper body and neck. · Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. · Ability to access and use a variety of computer software developed both in-house and off-the-shelf. · Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. · Frequently interacts with others to obtain or relate information to diverse groups. · Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. · Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. · Regular and consistent attendance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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