Sr Mgr, DM Programmer (DG)
New York, NY - Pharmaceutical & Biotech - Hybrid - Full time
Date Posted: 8/3/2023 1:49:06 PM
Senior Manager, DM Programmer Data Management
New York, NY - onsite 2 days in NYC
Position will be Contract or temp to perm
Seeking a Senior Manager, Data Management Programmer (Contract) within the Data Management Group. The DM Programmer is responsible for the effective development of study level EDC databases, reports/dashboard and system integration support. In addition, will support to setup a new eCRF library and perform library validation. CDASH/CDISC implementation experience is preferred.
Successfully manage multiple concurrent contract Clinical Data Management projects. Self-motivated, organized, and detail oriented while possessing excellent interpersonal and communication skills. Ideally you will be able to collaborate across diverse disciplines and thrive in a fast-paced environment.
Building, maintaining and deploying study databases to collect clinical trial data, including configuring study database internal module connections and external system integrations. Being responsible for initial study database development and changes required after initial deployment. Taking responsibility for more complex studies in the portfolio which may require additional expertise. Building the reports/dashboard for data management and clinical team for data review. Contributing to the development of appropriate timelines for development and deployment of study databases. Providing EDC technical expertise to Data Management and to the clinical study team members to support study decisions. Managing work assignments to ensure timely delivery. Identifying and resolving issues which may negatively impact delivery of work, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately. Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes. Training and/or mentoring newer EDC Database Development team members on key activities and processes. Contributing to the development and application of smart systems and optimal approaches to support the collection of data. Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability. Supporting preparations and follow-up actions related to Health Authority inspections and internal audits. Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing activities on behalf of company. Representing the Company in interactions with key external partners as part of any committee or industry group relating to global library development. Lead/Provide the relevant support to setup and validate standard global library.
A Bachelor’s degree in computer science, or equivalent is required. At least 5 years of global clinical trial expertise with a focus on EDC database development. 2 years of clinical database development experience in Veeva will be preferred. 2 years of reports/dashboard development experience (SAS, and JReview/Spotfire) is a plus. Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and EDC database development. Strong knowledge of industry leading EDC tools (e.g., Veeva CDMS, Medidata Rave, Oracle/Inform, etc.) and well versed in industry trends and emerging technologies supporting data collection. Strong knowledge of clinical study design. Strong knowledge of GCP/ICH guidelines. Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles. Understanding of database and dictionary structures (e.g. MedDRA, WHODrug). Experience with CDISC standards including CDASH and SDTM is desirable. Demonstrated partnership across various collaborative forums. Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.). Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.
Please contact Darren Gutowski at firstname.lastname@example.org