Description:
The Lead Clinical Data Manager (LCDM) is accountable for clinical data management activities in support of the clinical pipeline for complex studies. This includes, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff (dotted line), 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 LCDM interacts with senior level management, collaboration partners and provides cross functional strategic direction and is accountable for leading the data management activities for complex studies (i.e. Pearls) across functions to identify risks and opportunities as well as innovative approaches to clinical data management. The LCDM is critical to the success of our complex clinical trials and the integrity of data that supports regulatory submissions and decision-making.
Key Responsibilities:
- Works closely with the Sr. Manager, Clinical Data Management / Analytics in building an efficient and compliant data management function that meets industry standards and supports regulatory inspections.
- Driving global data management and data analytics strategy related to technologies and processes to increase efficiency, innovation and data quality for complex studies.
- Leads all data management aspects from startup to database lock, including Data Management Plans (DMP), Edit Checks, and Data Review Plans.
- Oversees the development and validation of Electronic Data Capture (EDC) systems, ensuring CDISC standards are met.
Skills & Experience:
Key competencies and characteristics needed to help build our diverse, inclusive culture and to be successful in the role. Examples include:
- Overseeing the collection, validation, processing and analyzing of more complex clinical trial data.
- Developing and implementing data management and data analytic procedures for clinical trials.
- Supporting and facilitating the review of medical coding for validity and completeness.
- Ensuring compliance with applicable regulations, protocols and standard operating procedures.
- Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock.
- Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management and data analytics.
- Develop and maintain data management documentation, including clinical study protocols, statistical analysis plans, case report forms and data management plans.
- Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
- Perform cleaning activities, including discrepancy management and query resolution.
- Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
- Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
- Collaborate with study team members to resolve data-related issues and discrepancies.
- Generate and review data listings, summaries and reports for clinical study reports.
- Serve as a primary or backup resource for issues about data management.
- 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 Clinical Study Managers 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 (trends) and improve processes.
Qualifications/Education:
- Bachelor’s degree in a scientific or healthcare-related field or a computer science degree or equivalent professional certification.
- 4-6 years of experience in clinical data management or a similar role in the medical device or clinical research industry.
- Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
- Proficiency in electronic data capture (EDC) systems (i.e. Veeva) and clinical data management software.
- 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 organisational and time management abilities.
Travel Requirements:
- Travel up to 5% of the time may be required to attend departmental or company meetings which may require overnight travel; however, these meeting would be 1-2 times per year.