Senior Clinical Data Manager
Disc Medicine is hiring a new Senior Clinical Data Manager (Sr. CDM) due to the fast growth of the programs in the clinic. Disc is currently initiating clinical trials with a biologic program (monoclonal antibody DISC-0974) 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 Sr. Clinical Data Manager (Sr. CDM) 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 Sr. CDM will ensure consistency of data collection and data standards across projects and systems.
RESPONSIBILITIES OF SR. CDM:
- 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 achieves 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
- B.A./B.S. in science/health-related field with 6+ 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
ABOUT DISC MEDICINE:
The people at Disc Medicine are dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by a seasoned, collaborative team of scientists and industry experts committed to innovative programs that advance the frontiers of medicine. Disc Medicine values transparency, authentic communication, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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