The Associate Director of Data Integration & Innovation (DII) is responsible for developing and enhancing digital technology as well as overseeing all technologies used within the Global Clinical Data Management (GCDM) department. The position manages complex abstract clinical data management technical projects and is responsible for tasks used to define how and where technologies are applied to collect, code, review, validate, and visualize clinical trial data received in-house and remotely.
Activities used in the management and overseeing of technologies are performed to ensure complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions; and seamless transfer of data from source to data visualization using electronic feeds (e.g. API).
Activities are performed according to external regulatory requirements, and internal standard operating procedures (SOPs), accepted industry best practices and established project deadlines. The position assists in the implementation of the corporate strategic plan in the GCDM department with the adoption of future technologies and manages the certain components of the GCDM budget where appropriate.
- Support the Director, Data Standards, Integration & Innovation to implement a roadmap for emerging digital technology (e.g. artificial intelligence, electronic health record, etc.) to drive Alexion into next generation technology.
- Facilitate in the development of a strategic roadmap for enhanced data mapping from source to reporting in both data visualization platforms and in delivery to the Quantitative Sciences (Biostatistics) business group.
- Develop integration specifications and implement integration of both metadata and data point specific systems including, but not limited to, CTMS-like reporting metrics, vendor management oversight, sample tracking, eCONSENT, eCRF, AE/SAE safety indicators, etc. in order to provide a comprehensive user-friendly dashboard for predictive, risk-based monitoring of clinical trial information.
- Create platforms and processes for GCDM process, including data flow maps where technology is utilized in the efficient and effective collection of all data sources which result in data review, visualization, and regulatory reporting.
- Support the Data Standards lead in developing core CRF standards in a validated repository tool which includes ODM terminology and allows for visual presentation to stakeholders prior to CRF standards acceptance and EDC adoption.
- Provide Medidata Rave expertise for core configuration, coding dictionary uploads, and maintain the administrator role for all Medidata related activities.
- Drive an integrated rollout strategy for implementation of new processes, standards, and/or technologies to ensure clear scope, comprehensive communication, training, assessment, and continued improvement opportunities for internal personnel and outsourced provider(s).
- Assess corporate goals and business strategies to identify opportunities for implementing new cross-functional/organizational policies and methodologies as related to process changes, data collection standards, and data visualization synergies.
- Coordinate with strategic resourcing for the development of request for proposals (RFPs) for external vendor cross-functional/organizational contracts supporting GCDM data standards, process change and/or technology recommendations.
- Review external vendor cross-functional/organizational contracts and budget for appropriateness to the project to ensure adherence to GCDM technology recommendations.
- Oversee budget forecasts, accruals and invoices for cross-study, non-operational activities (e.g., software licensing, coding dictionary licensing)
- Serve as subject matter expert on regulatory audits for data standards and technical CDM activities.
- Experience in clinical data management for a minimum of 7 years
- Expert with the electronic data capture (EDC) system Medidata/RAVE.
- Experience with additional Medidata suite products (e.g., RTSM, Safety Gateway, ePRO, eCONSENT, etc.).
- Experience with data integrations between clinical databases and industry standard systems (e.g., CTMS, ePRO, IXRS, Argus).
- Experience with data visualization tools (e.g., Spotfire, Looker, etc).
- Proficient with the development of CRF/eCRF for clinical trials and its impact into database design/development.
- Proficient in the design and validation of data collection instruments as well as data standardization, theory, design, collection, review, analysis, and display for implementation of standards across the Alexion organization.
- Proficient with oversight of: CDASH/CDISC (SDTM terminology), MedDRA and WHO-DD dictionary coding and versioning, SAS for data review, and software platforms across the biotechnology/pharmaceutical industry.
- Possess a thorough knowledge of medical terminology and the clinical data management and the clinical trial process.
- Proficient on regulatory requirements for data management and the regulatory submission process.
- Proficient on developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement. Approve contracts.
- Proficient in working on abstract problems across functional areas of the business, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data.
- Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company.
- Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
- Requires a Bachelor’s degree in a scientific discipline, information technology discipline or equivalent.
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.