About BBOTBBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com Who You AreThis is an exciting opportunity for a highly motivated Director or Senior Director with a strong background in Data Management in the oncology biotech and pharma space. We are looking for a talented and enthusiastic individual who thrives in a collaborative, fast-paced, and growing environment to join our team as a Clinical Data Management leader with responsibility for the delivery and integrity of clinical data across BBOT’s multiple studies and programs. As a key member of the Development team, you will: Responsibilities· Provide data management input for clinical study teams and the Development department. Represent and communicate data management activities, progress, and risks to cross- functional leads.· Lead and manage clinical data management tasks and activities for assigned clinical trial(s) from study start up to study closeout· Manage and provide oversight of vendors (including clinical data management CRO) to ensure the data are complete, accurate and delivered within the agreed upon timelines, including timely filing of all DM related plans and documents to eTMF· Oversee Data Management functional budget and perform budget review for outsourced data management activities· Ensure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with training· Work collaboratively with internal and external team members within the study to coordinate the planning and execution of clinical data management activities and data deliverable timelines in support of overall clinical development strategies· Create strategies for rapid study start and database lock to increase clinical data management productivity· Oversee CRO EDC database build and lead the design of eCRFs and ensure that they align with the clinical protocol(s)· Ensure complete and accurate documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans· Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, TLFs, etc. that are generated for Regulatory Agency interactions, CSRs, DSURs, IBs, and other business needs; collaborate with programming to identify data cleaning gaps to create additional line listing outputs and facilitate internal medical line listing review / issuing and resolving queries· Collaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standards· Help establishing CDM processes and contribute to the development of key clinical data management SOPs· Provide technical support and guidance for clinical data management team and vendors around project conventions, standards, practices, and database specifications