Associate Director, Clinical Data

ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENTReporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Responsibilities

(including, but not limited to) :Drive and lead the development of all databases and eCRF designPlan, develop and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelinesDevelop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studiesReview and provide expertise on all eCRF changes, respond accordingly to make resulting database changesOrganize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plansOversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of eachAccountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaningReview, track, and report status of all data management project(s) to senior leadershipResponsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliationMaintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendorsDevelop data management SOPs and processes that align and address business priorities; Contribute to cross-functional SOP developmentUphold a reputation for data integrity and complianceRequirementsRequires a Bachelor’s degree within a scientific discipline (advanced degree a plus) with a minimum of 10+ years of experience within biotech/biopharma and/or CRO organizationExtensive knowledge and experience in clinical data managementDirect experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standardsExtensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management PlansComprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulationsDemonstrated experience in managing multiple CROs/vendorsDemonstrated strong written and verbal communication skillsProven mindset of proactive continuous improvementEfficient independent worker with ability to focus and drive for resultsStrong attention to detailAbility to work in a fast paced-environment and to handle multiple tasksStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)The salary range for this position is commensurate with experience

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