Specialist , Data Stewardship

Primary activities include, but are not limited to:

• 40% Oversees and coordinates clinical database activities for multiple clinical programs. Interface with CDS manager/supervisor to assure consistency of technical and process strategies. Acts as a technical resource to other members of the group. Plans appropriately to ensure adherence to timelines. Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
• 20% Creates and develops clinical databases and data transfer files according to written specifications. Ensures adherence to clinical database standards, SOPs and Process Guidelines. Leads and participates in the review of eCRFs and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).
• 20% Trains new hires and participates in the interview process. Provide ongoing training and development to Clinical Database Developers on existing standards. Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.
• 15% Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate CDS technical initiatives . Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing clinical database support to other departments.
• 5% Assist clinical database manager/supervisor in project planning, manpower projections and resource allocations across therapy areas. Interface with clinical database manager/supervisor to assure consistency of technical and process strategies across all therapy areas., Contingent Workforce Business Requirements Stakeholder Management Artificial Intelligence Requirements Management Verbal Communication Skills Database Storage Structures +0

Writing Leadership Innovation Compassion Data Files Mathematics Multitasking Adaptability Communication Data Analysis ICH Guidelines Data Cleansing Data Reporting Drug Discovery FDA Regulations Data Validation Customer Service Project Planning Computer Science Oracle Databases Telephone Skills Clinical Research Microsoft Windows Project Management Regulatory Affairs Medical Terminology Contingent Workforce Database Programming Database Development Organizational Skills Data Quality Assurance, * A B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience., * 4 years of database development or data cleaning programming experience, at least 3 of which including clinical databases and programming.

• Demonstrated strong technical proficiency in a Clinical Data Management System. Particularly Veeva EDC, Central Designer, SQL-PL/SQL.
• At least 4 years' experience with Oracle databases and SQL.
• Solid knowledge of MS Windows/Office software and exposure to web-based applications.
• Ability to establish and maintain good working relationships with different functional areas. * Strong sense of urgency and customer focus. * Project Management skills * Ability to present in a group environment * Leadership, verbal and written communication, interpersonal and organizational skills * Desire and ability to learn new processes and technologies * Broad knowledge of Clinical Development and Regulatory Affairs requirements * Ability to multi-task, work independently, and good communication skills * Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11., Adaptability, Clinical Database Programming, Clinical Data Management, Clinical Programs, Clinical Research, Communication, Data Analysis, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Good Clinical Practice (GCP), Medical Terminology, Project Management, Teamwork, Tooling Biology Oncology Operations Management Automation Governance Innovation Compassion Databricks Scalability Data Quality Data Lineage Life Sciences Data Modeling Data Strategy Problem Solving Data Governance Data Management Computer Science Telephone Skills Data Engineering Issue Management Change Management Business Analysis Quality Management Operationalization Workflow Management Root Cause Analysis Information Systems Analytical Thinking Metadata Management, Veeva Writing Leadership Innovation Compassion Data Files Mathematics Multitasking Adaptability Communication Data Analysis ICH Guidelines Data Cleansing Data Reporting Drug Discovery FDA Regulations Data Validation Customer Service Project Planning Computer Science Oracle Databases Telephone Skills Clinical Research Microsoft Windows Project Management Regulatory Affairs Medical Terminology Contingent Workforce Database Programming Database Development Organizational Skills Data Quality Assurance Training And Development Pre-Clinical Development Clinical Data Management Electronic Data Capture (EDC) Good Clinical Practices (GCP) Clinical Data Management Systems Title 21 Of The Code Of Federal Regulations Structured Query Language Procedural Language (SQL PL) +0

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.