Clinical Data Manager

Clinical Data Manager

Vacancy expired!

CLINICAL DATA MANAGER
BERKLEY HEIGHTS, NJ
Project Description:
The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential to the sustainability and success of the Client's R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Clinical Operations (GCO).Specifically, the Associate Director, Clinical Data Management (Data Management Lead) is accountable for:

• Providing leadership of clinical data management activities across one or more clinical development programs enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making regulatory approval and market acceptance.
• A key role (Data Management Lead) that serves as the primary point of contact to the wider clinical trial team for clinical trial data related matters. The DML will, in turn, coordinate activities across clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting.
• A consistent approach to the gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness at all times.
• Leading activities with external vendors developing systems/applications for clinical trial data collection (e.g., ePRO/eCOA) to ensure quality and timely deployment.
• Implementation of the Data Quality Management Plan (DQMP) defining and documenting the data quality review strategy for each clinical trial in collaboration with various Client stakeholders (e.g., statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data supporting regulatory filings, publications, and other high-profile business activities.
• Supporting clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs/ePROs/eCOAs.
• Ensuring effective quality oversight and management of external partners (e.g., Function Service Providers, CROs, technology providers, etc.) performing data management services on behalf of the Client.
• Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.
• Participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.
• Representing the Company in interactions with key external partners as part of any committee or industry group relating to data management.
• Developing strong and productive working relationships with key stakeholders throughout the Client with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Required Skills:

• Bachelor's degree required with an advanced degree preferred. At least 5 years of relevant industry experience. Project management certification (e.g., PMP) is desirable.
• Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.
• Knowledge of industry leading eCRF tools (e.g., Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
• An understanding of database and dictionary structures (e.g., MedDRA, WHODrug).
• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
• Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.
• A good understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.
• Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
• Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.
• Leadership and communication capabilities with a proven ability to engage, manage, develop, and inspire a geographically diverse team.

This 12+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #21-00568
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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