Sr Director CDM
- R+D/ Global Development Support
- Greater Boston area
- Salary range: $240-260k base, bonus + additional benefits
A pharmaceutical company is looking to hire a Sr Director CDM. This position will report to the VP, Biometrics, the Senior Director will be accountable for global delivery, reliability and quality of clinical data across the portfolio. This candidate will provide leadership, guidance, high-level expertise to the clinical data management function. This candidate will operate as the in-house data management expert and provide consultation to all functions. This position will also have strategic responsibility for oversight of Contract Research Organization (CRO) activities related to data management, involving project management, vendor management, and coordination of internal reviews.
The Sr Director CDM position will have responsibilities that include:
- Lead data management function and oversee CRO data management activities that support ongoing clinical programs
- Supports leadership of evolution and improvement of data processes, systems and organization in alignment with other development functions
- Lead enhancement of the Data Management Plan (DMP) across programs and maintain throughout lifecycle of study project to ensure DMP is followed according to study design and requirements
- Evaluate clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis)
- Lead EDC database (DB) specification process internally
- Assess / Develop DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
- Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
- Reconcile electronic data transfers from vendor to Sponsor
- Supervise the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report
- Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials
- Guarantee clinical data within EDC is of superior quality to support lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding
- Responsible for eDairy, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective
- Support in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
- Present close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs
- Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB
- Direct and communicate with DB vendors on consistent basis to address Clinical team's requests, project plans, and/or eCRF development activities
- Participates in the preparation and presentation of data, when applicable
The ideal candidate will have the following skill set:
- Requires a Bachelors Degree or higher in a scientific discipline with 10+ years of clinical data management leadership experience in pharma/biotech
- Competent in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in a pharmaceutical industry/clinical research company
- Knowledge working in an outsourced data management model
- Understanding of and familiarity with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
- Fluency with GCP, ICH and FDA requirements as applicable for clinical data management
- Previous experience filing a BLA or NDA preferred
- Demonstrated leadership in a cross-functional team setting
- Capability to manage multiple initiatives and shifting priorities within a small company environment
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
