Black Diamond Therapeutics Inc Sr. Manager, Data Management in Cambridge, Massachusetts
Black Diamond Therapeutics is a next-wave cancer precision medicine company. Black Diamond is at the forefront of developing selective medicines for patients with genetically defined cancers driven by oncogenes activated by allosteric mutations. Leveraging its innovative mutation, allostery, and pharmacology (MAP) computational and discovery platform, Black Diamond is revolutionizing the field by uncovering novel ways to functionally assess the mutational landscape of individual oncogenes. This approach allows us to discover and validate new targets and develop highly selective therapeutics that offer new hope to cancer patients.
The Sr. Manager, Data Management will play a critical role in leading our data management activities, ensures that program and study level deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. This position requires a strong background in data management, excellent leadership skills, and the ability to collaborate with cross-functional teams. The successful candidate will contribute to data management oversight, data delivery, and ensure regulatory compliance.
Oversee the activities of applicable Data Management study vendors and CRO Data Management functional counterparts to ensure adherence to scope of work and service agreements, to ensure deliverables are met in accordance with study milestones/timelines and with expected data quality.
Collaborate closely with relevant functions within Black Diamond Therapeutics (clinical development, translational medicine & clinical science, clinical operations, clinical pharmacologists, drug safety, regulatory, etc.) to design and conduct clinical studies, with a focus on data management.
Develop and guide team members through the development of DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
Oversee data review and querying processes, ensuring timely and accurate clinical database lock.
Lead and execute data management oversight activities on clinical studies, including guidance on building clinical databases, and developing timelines.
Represent the data management function in clinical sub-teams, and project teams at Black Diamond Therapeutics, providing timely and effective input and updates.
Lead cross-functional Data Review Working Group, if established, to ensure comprehensive data review processes.
Ensure timely and accurate collection, review, and analysis of clinical data, adhering to GCP compliance standards and corporate policies at Black Diamond Therapeutics.
Support, development and expand Data Management, systems, templates, processes and responsibilities across department toward overall operational standardization.
Collaborate with IT to ensure secure and proper collection and storage of clinical data, including clinical pharmacology and biomarker data at Black Diamond Therapeutics.
Provide outputs and develop review tools (e.g., J-review, Spotfire) to support ongoing clinical data review by clinical development and translational & clinical science functions at Black Diamond Therapeutics.
Monitor quality of data deliverables from external vendor sources used for the clinical database for all assigned studies with focus on assessing and producing metrics on overall database trends, including but not limited to EDC, eTMF, etc.
Identify, lead the selection process, and manage contractors and vendors to ensure successful execution of data management goals, in cooperation with clinical development, development operations, and finance at Black Diamond Therapeutics.
Effectively manage consultants across the data management function, if applicable, at Black Diamond Therapeutics.
Bachelor's degree in life sciences, computer science, statistics, or a related field.
Minimum of 7 years of experience as Senior or Lead Clinical Data Manager
Oncology experience desired
External Company Name: Black Diamond Therapeutics Inc.
External Company URL: www.blackdiamondtherapeutics.com
Street: One Main Street