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data manager Bridgewater, NJ

Mallinckrodt Pharmaceuticals

Full Time Bridgewater, NJ 163004 - 110668 USD ANNUAL Today

Job description

Job Title

Manager, Data Management

Requisition

JR000013349 Manager, Data Management (Open)

Location

US Specialty Brand Headquarters - USA501

Additional Locations

Bridgewater, NJ

Job Description

Summary

The Manager, Data Management is a key role within the Evidence Generation & Data Sciences (EGDS) department. This role is responsible for overseeing the data management function within the organization. This position involves managing and ensuring the quality, integrity, and timely delivery of clinical trial and research data. The incumbent plays a crucial role in implementing data management processes, ensuring compliance with regulatory guidelines, and collaborating with cross-functional teams. The leader also manages external vendors and partners and maintains data quality control procedures. Strong leadership, organizational skills, attention to detail, and a solid understanding of data management principles are essential for success in this role.

Principal Responsibilities and Key Requirements

Data Management Oversight: Provide leadership and guidance to the data management team, ensuring efficient and effective data collection, cleaning, and validation processes; develop and implement data management strategies and standard operating procedures (SOPs) to ensure high-quality and compliant data management practices; oversee the development and maintenance of data management plans, data transfer agreements, and data validation specifications; collaborate with cross-functional teams to ensure data integrity, accuracy, and completeness throughout the data lifecycle.
Data Collection and Database Design: Work closely with cross-functional teams to define and implement data collection strategies and data capture systems; collaborate with clinical and statistical teams to ensure appropriate data standards and compliance; oversee the development and maintenance of electronic case report forms (eCRFs) and electronic data capture (EDC) systems; ensure proper database design, validation, and user acceptance testing to facilitate accurate and efficient data capture.
Vendor Management: Evaluate, select, and manage external vendors and partners for data management activities; establish and maintain effective relationships with vendors to ensure timely and quality deliverables; collaborate with vendors to define data management specifications and ensure compliance with regulatory requirements; conduct regular vendor performance assessments and address any issues or concerns that arise.
Quality Control and Compliance: Implement data quality control procedures and conduct ongoing quality reviews to identify and resolve data discrepancies and inconsistencies; ensure compliance with regulatory guidelines, industry standards, and data privacy regulations; collaborate with cross-functional teams and quality assurance (as appropriate) to address data-related audit findings and implement corrective actions; stay updated on emerging trends, technologies, and best practices in data management to enhance processes and ensure compliance.

Minimum Requirements

Education / Experience / Skills:

A minimum of a bachelor’s or master’s degree in Computer Science, Data Science, or related field is required.
At least 6 years of relevant experience in data management roles within the pharmaceutical, biotechnology, or medical device industry; clinical system management, database or SAS programming experience desirable.
Strong knowledge of clinical trial data management principles, data standards, and regulatory requirements.
Proficiency in clinical data management systems (e.g., EDC systems) and electronic data capture technologies.
Familiarity with data management software and programming languages commonly used in data management.
Experience in managing and leading data management teams as well as vendor management.
Excellent organizational, project management, and problem-solving skills.
Strong attention to detail and ability to prioritize and manage multiple tasks simultaneously.
Effective communication and interpersonal skills to collaborate with cross-functional teams and external partners.

Organizational Relationship/Scope:

The Manager, Data Management reports directly to the Director, Biometrics. This role will partner with and positively influence other R&D colleagues including Clinical Development & Medical Affairs, Research & Development Operations, Evidence Generation & Data Sciences, Regulatory Affairs & Pharmacovigilance, and Program Management; Marketing, Market Access, Commercial Effectiveness, Communications, Legal, Healthcare Compliance, Procurement, Finance, and other departments (as appropriate).

Working Conditions:

Position is remote.

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