Senior Clinical Data Manager

About this role

Responsibilities

• All responsibilities of a Clinical Data Manager (CDM).
• May be responsible for in-life and database lock tasks and activities.
• Assume data management responsibilities for larger, more complex or higher priority protocols.
• Triage, research, discuss and resolve the reports outputs provided by Clinical & Statistical stakeholders at a protocol level during in-life and database lock stages. Execute special reports in different systems and coordinate resolution of the outputs.
• Responsible for the preparation, creation, validation and review of data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
• Coordinate User Acceptance Testing (UAT) of the Clinical Database.
• Responsible for communication with Clinical team regarding site level issues on a protocol.
• Coordinate communications, global status tracking and issue resolution at study level.
• Interact and communicate with customers and stakeholders both internal and external to GDMS as well as internally when needed.
• Responsible for study level status assessment, reporting and communication with LCDM, or with the assigned trial manager.
• Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to appropriate parties.
• May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines and provide data entry status to Clinical stakeholders.
• Coordinate and mentor CDMs and other SCDMs who work in same protocol to maintain compliance with SOPs, data management plans and data review plans.
• Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.
• May contribute to special activities such as supporting Process Owner (PO) Models in the local data management center and/or in the Global PO networks.
• Participate in cross functional technical or process improvement projects.
• Required Skills:
• Adaptability, Adaptability, Business Management Software, Clinical Databases, Clinical Data Cleaning, Clinical Data Management, Clinical Trials, Customer-Focused, Data Analysis, Database Development, Database Management Systems (DBMS), Data Integrity, Data Processing, Data Quality Assurance, Data Review, Data Validation, Data Visualization, Electronic Data Capture (EDC), Good Clinical Practice (GCP), Integrity Management, Learning Agility, Management Control Systems, Pharmacovigilance, PL/SQL (Programming Language), Quality Management {+ 1 more}
• Preferred Skills:
• Current Employees apply
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• Current Contingent Workers apply
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• Search Firm Representatives Please Read Carefully
• 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.
• Employee Status:
• Regular