Associate Director/Director of Clinical Data Management
Disc Medicine is hiring a new Associate Director/ Director of Clinical Data Management due to the fast growth of the programs in the clinic. This position is located within Disc Medicine’s Watertown, MA office, although remote work is currently in effect and open for this role. We are looking for someone to be an integral member of the Clinical Development team and will be responsible for the life cycle of clinical data from collection to delivery for statistical analysis in support of the Disc Medicine portfolio. As an experienced director with broad knowledge of all areas of CDM processes and systems, the candidate will provide operational input, technical leadership, and hands-on support to study teams in the design, documentation, testing, and deployment of Electronic Data Capture (EDC) systems and all external clinical data systems.
- Set vision for CDM strategies, operations, infrastructure, and technology.
- Establish sound processes to ensure data quality/integrity and regulatory compliance.
- Promote standardization, automation, innovation, process improvement, and technology enhancement in CDM and beyond to increase drug development efficiency.
- Proactively drive quality and efficiency to meet timeline and milestones for CDM, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with cross functional study team(s).
- Lead the development and implementation of policies, standards and process improvement initiatives related to CDM.
- Actively identify risks, develop risk mitigation plans, and execute plans.
- Report progress, status, risks, timelines, and needs to stakeholders.
- Establish CDM vendor management strategies and provide oversight and guidance to CROs to ensure timely delivery and regulatory compliance of outsourced activities.
- Develop, review and provide input to relevant vendor RFIs, RFPs, proposals and contracts.
- Ensure quality database design including documentation, testing, validation, and implementation of clinical data collection tools, both CRF and non-CRF, using an Electronic Data Capture (EDC) system and/or other data collection systems.
- Serve as a technical resource to the study teams for CDM standards, tools, data provisioning, and reporting.
- Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data visualization, data access, and database lock.
- BS in a relevant field. MS preferred.
- 10+ years data management experience in pharmaceutical or biotechnology with progression of responsibility in tasks, job duties, and/or roles that have demonstrated growth and/or advancement in complexity, difficulty, or level of responsibility.
- Experience working in start-up environment preferred.
- Proven ability to independently determine the most appropriate methods and procedures across CDM projects.
- Advanced writing and verbal presentation skills, with the ability to convey complex/technical findings to varied audiences and build alignment around a topic/issue.
- Experience in managing multiple CROs and DM vendors.
- Advanced working knowledge of data management principles, including knowledge of relevant Data Standards (i.e. CDISC/ADaM).
- Solid knowledge of the drug discovery and development process, clinical trial methodology, FDA & ICH, GCP, GCDMP, and worldwide regulatory requirements.
- Familiarity with MedDRA/WHO-Drug.
- Experience using data visualization tools (e.g. Spotfire, jReview).
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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