Receiving general directionfrom the Director of the Neurological Clinical Research Institute (NCRI) andNCRI Director of Data Management, the Senior Data Manager will be responsiblefor overall data management of assigned multi or single center clinicalresearch activities led by the NCRI. The candidate will provide oversight forall aspects of the data management activities necessary to start, conduct andclose out of assigned multi or single center clinical trials. The candidate will be responsible for thedesign, implementation and ongoing management of a system to review and re-codemedical information related to clinical research. The candidate will generatereports to various committees, funding organizations, and regulatory officesfor large multi-center clinical trials coordinated through the MGH NCRI.Responsibilities also include participation in developing and maintaining bestpractice guidelines, study tool templates, Standard Operating Procedures, aswell as providing guidance to junior staff members on specific area ofexpertise.
PRINCIPALDUTIES AND RESPONSIBILITIES:
Responsibilities for the SeniorData 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-specificelectronic data capture system
Developing programs to check the integrity of thedata, including range, error, and logic checks
Reviewing data and assisting data safety report generationon regular basis
Develop and manage process for adverse event monitoringand 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 developerfor all segments of the new functionality
Elicit, compile and present feedback from othermembers 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).
Standard Office conditions.Will travel for conference and study team meeting as needed.
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.)
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.
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.