Sr. Clinical Data Manager
Massachusetts General Hospital(MGH)

Job Info

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GENERAL SUMMARY/ OVERVIEW STATEMENT:

Receiving general direction from the Director of the Neurological Clinical Research Institute (NCRI) and NCRI Director of Data Management, the Senior Data Manager will be responsible for overall data management of assigned multi or single center clinical research activities led by the NCRI. The candidate will provide oversight for all aspects of the data management activities necessary to start, conduct and close out of assigned multi or single center clinical trials. The candidate will be responsible for the design, implementation and ongoing management of a system to review and re-code medical information related to clinical research. The candidate will generate reports to various committees, funding organizations, and regulatory offices for large multi-center clinical trials coordinated through the MGH NCRI. Responsibilities also include participation in developing and maintaining best practice guidelines, study tool templates, Standard Operating Procedures, as well as providing guidance to junior staff members on specific area of expertise.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Responsibilities for the Senior Data Manager include:

• All aspects of study start up and conduct for multi-center and single center clinical trials:
  • Participating in protocol review and development
    
  • Facilitating the study kick-off meeting
    
  • Development/design of Electronic Case Report Forms (eCRFs)
    
  • Designing, testing and validating the study-specific electronic data capture system
    
  • Developing programs to check the integrity of the data, including range, error, and logic checks
    
  • Reviewing data and assisting data safety report generation on regular basis
    
  • Develop and manage process for adverse event monitoring and reporting
    
  • Assisting study sites with any Electronic Data Capture (EDC) system related questions or problems
    
  • Perform regular internal audit on the above activities
    
• Drawing on previous data management experience and knowledge of FDA regulations, participate in the design and implementation of any new modules for the NCRI Clinical Trial Management System (CTMS) as well as proposed changes to the existing system
  • Develop workflow schema's for any new functionality
    
  • Provide direction and guidance to program developer for all segments of the new functionality
    
  • Elicit, compile and present feedback from other members of NCTU regarding proposed functionality for EDC/CTMS.
    
• Accept responsibilities for special projects as requested
• Ability to work independently
• Ability to develop and manage positive relationships with both academic and industry sponsor representatives
• Ability to provide guidance to team members
• In depth understanding of Good Clinical Data Management Practice guidelines and relevant FDA regulations, and the ability to implement these principles appropriately, and advise team members on implementation
• Basic understanding of drug manufacturing process and ability to interpret relevant regulations and guidelines as needed
• Ability to manage multiple studies and provide training on technical skills
• Assist with developing and maintaining best practice guidelines, study tool templates and Standard Operating Procedures for the NCRI
• Ensure the required study-specific DM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
• Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).

WORKING CONDITIONS:

Standard Office conditions. Will travel for conference and study team meeting as needed.

Qualifications
QUALIFICATIONS: .

• Bachelors degree required
• 3 + years of experience in clinical data management required
• Experience with web based EDC or CTMS
• Demonstrated knowledge of data management processes and principles in area of responsibility
• Working knowledge of clinical research, industry standards (CDISC), FDA & ICH, GCP, GCDMP, and related regulatory requirements
• Familiarity with MedDRA/WHO-Drug
• Demonstrates strong verbal and written communication skills including ability to communicate remotely
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

SKILLS/ABILITIES/COMPETENCIESREQUIRED:

Basic computer knowledge andknowledge of MS Office application is a must. Understanding of clinicalresearch methodology and regulations is essential. Experience in clinical data management isrequired. Good leadership, presentationand writing skills as well as, ability to interact well with others, takeinitiative and think independently are also required.

EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.

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