ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule.
2 Days a week in office (3 days WFH)
Reporting 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.
Responsibilities (including, but not limited to) :
- Drive and lead the development of all databases and eCRF design
- Plan, develop and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals / guidelines
- Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies
- Review and provide expertise on all eCRF changes, respond accordingly to make resulting database changes
- Organize 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 plans
- Oversee and build strong sustainable relationships with multiple global CROs / vendors along with managing the process and coordination of each
- Accountable 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 cleaning
- Review, track, and report status of all data management project(s) to senior leadership
- Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation
- Maintain 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 vendors
- Develop data management SOPs and processes that align and address business priorities; Contribute to cross-functional SOP development
- Uphold a reputation for data integrity and compliance
Requirements
- Requires 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 organization
- Extensive knowledge and experience in clinical data management
- Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards
- Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans
- Comprehensive 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 regulations
- Demonstrated experience in managing multiple CROs / vendors
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast paced-environment and to handle multiple tasks
- Strong commitment to ethical standards
- Proficient 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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