Manager, Clinical Data Management

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. 

COMPANY OVERVIEW:

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

POSITION OVERVIEW:

Disc Medicine is hiring a new Manager, Clinical Data Management due to the fast growth of the programs in the clinic.  Disc is currently initiating clinical trials with a biologic program and a small molecule (bitopertin).  

This position will report to the Director of Clinical Data Management and is located within Disc Medicine’s Watertown, MA office, although remote work is currently in effect and open for this role.  The Manager, Clinical Data Management is responsible for the management and/or oversight of all data management activities for one or more clinical trials. Essential responsibilities may include the oversight and/or management of external vendors (e.g. CROs) for any outsourced data management activities and/or the coordination of data management activities internally as appropriate. The Manager, Clinical Data Management will ensure consistency of data collection and data standards across projects and systems. 

RESPONSIBILITIES:

• Actively participate in the entire life cycle of clinical trial data management independently. 
• Interact and collaborate with trial managers, other internal team members and vendors to support the set-up, maintenance, and close out of the data management aspects of clinical trials to ensure high data quality. 
• Oversee the design of the eCRF to ensure consistency with study protocol, clinical requirements, and accurate and efficient data collection. 
• Coordinate and track progress of eCRF build to ensure projects meet timelines and achieve high data quality standards. 
• Oversee the creation and review of data validation check specifications. 
• Coordinate with internal team members to complete a thorough User Acceptance Testing (UAT) on eCRF and data validation checks and correspond with database development vendors to ensure proper corrections are made and approved. 
• Ensure the development, review and maintenance of project data management documents according to SOP, Work Instructions and/or Good Clinical Practice (GCP), including eCRF Completion Guidelines (eCCG), Data Management Plan (DMP), Data Validation Specification (DVS) etc. 
• Ensure project data management documents are consistently filed within the project’s Trial Master File (TMF). 
• Oversee and/or lead data review process and query resolution to ensure database lock is obtained according to agreed timelines and at a high level of quality. 
• Assist in the generation and maintenance of data management documents, SOPs, and guidelines. 
• Facilitate efficient communication to ensure deadlines are met. 
• Provide periodic and ad hoc reports of study data and study progress. 
• Perform any other business need identified by their direct line Manager. 

 REQUIREMENTS:

• B.A./B.S. in science/health-related field with 5+ years of experience in Clinical Data Management in the Pharmaceutical/Biotechnology/Medical Device industry is preferred, or equivalent combination of education and experience 
• Advanced skills in various Electronic Data Capture (EDC) systems (e.g. Medidata Rave and IBM Clinical Development) 
• Experience in the entire life cycle of data management in clinical trials including EDC build, trial start-up, trial conduct and trial close out activities on global trials 
• Strong knowledge of industry best practices in clinical data management, and understanding of clinical trial methodology, clinical research and GCP regulations 
• Understanding of CDISC data models (CDASH, SDTM, ADaM) and support of data standardization preferred 
• Coding experience with MedDRA and WHO Drug a plus  
• Experience with RAVE and/or RAVE Architect, IBM Clinical Development a plus 
• SAS programming knowledge a plus 
• Detail oriented with strong prioritization skills 
• Ability to handle multiple projects and changing priorities 
• Excellent interpersonal, communication and leadership skills 
• Must be results-driven and exhibit a sense of urgency 
• Clear and concise in verbal and written communication, foster smooth flow of timely and relevant information 
• Demonstrated ability to work independently 
• Strong initiative and positive attitude 
• Proven ability to support and build collaborative relationships both internally and externally

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. 

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.