Sr. Manager, Data Management & Data Analytics

ConvaTec • Lexington, MA

78d

About The Position

The Senior Manager of Clinical Data Management & Analytics (Sr. Manger, CDMA) is accountable for all clinical data management and data analytics activities in support of the clinical portfolio. This includes, but is not limited to, execution and ownership of the Clinical Data Management (CDM) and Clinical Data Analytics (CDA) operating models, oversight of internal staff, and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance. The Sr. CDMA interacts with senior level management, collaboration partners and provides cross functional strategic direction and is accountable for building and managing the Clinical Data Management and Data Analytics teams across functions to identify risks and opportunities as well as innovative approaches to clinical data management and data analytics. The Sr. CDMA is critical to the success of our clinical trials and the integrity of data that supports regulatory submissions and decision-making.

Requirements

• Bachelor's degree in a scientific or healthcare-related field or a computer science degree or equivalent professional certification.
• 8-10 years of experience in clinical data management or a similar role in the medical device or clinical research industry.
• Proven track record of building and scaling high-performing global data management teams while ensuring regulatory compliance and data integrity.
• Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
• Proficiency in electronic data capture (EDC) systems and clinical data management software. Experience with Veeva is a plus.
• Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
• Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
• Excellent attention to detail with problem-solving and analytical skills.
• Strong organizational and time management abilities.

Responsibilities

• Establishing and driving global data management and data analytics strategy related to resourcing, technologies and processes to increase efficiency, innovation and data quality.
• Leading the global data management and data analytic functions to provide data collection, cleaning, and integration expertise in support of global development projects including all disease areas and business units; ensure functional strategy supports the clinical portfolio priorities while also remaining close to the business and clinical portfolio.
• Building efficient and compliant processes to support regulatory inspections.
• Ability to effectively structure a data management / data analytics organization to manage the anticipated growth in the global product pipeline.
• Manage vendors contracted to support the data management and data analytics services needed to support data management and data analytical milestones for Convatec clinical trials.
• Ability to build and scale high-performing global data management teams while ensuring regulatory compliance and data integrity.
• Ability to combine strategic leadership with technical expertise to optimize clinical data management processes and drive organizational growth.
• Collaborate with Head of Clinical Operations and other key members to elevate the Clinical Data Management and Data Analytics function at Convatec.
• Overseeing the collection, validation, processing and analyzing of clinical trial data.
• Developing and implementing data management and data analytic standard operating procedures for clinical trials.
• Supporting and facilitating the review of medical coding for validity and completeness.
• Maintain the highest data quality standards throughout the data lifecycle, from data collection to data analysis.
• Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management and data analytics.
• Develop and maintain data management and data analytics study documentation, including clinical study protocols, statistical analysis plans, case report forms and data management plans.
• Oversee the designing of case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
• Ensure compliant cleaning activities, including discrepancy management and query resolution practices are in place.
• Oversee data validation checks and implement quality control measures to ensure accuracy and completeness.
• Collaborate with study team leaders to resolve data-related issues and discrepancies that have been escalated.
• Review data listings, summaries and reports to ensure accuracy and quality standards are met for all clinical study reports.
• Serve as a primary or backup resource for issues about data management and data analytics.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the development and validation of data management software tools.
• Oversee the data analytics for Convatec clinical trials to ensure data analyses are performed on time and within budget.
• Collaborate with the Head of Clinical Operations in leading the data analytics for the various clinical trials to ensure robust analyses are conducted per protocol and to identify patterns in the data.

Benefits

• Remote Working

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees