- Develop, build, and maintain databases of clinical trial data and establish tracking tools to track study-related data per the protocols
- Contribute to the development of study-specific data management processes including Statistical Analysis Plans, Data Management Plans, Case Report Forms, and other study documentation
- Collaborate with project managers, project leads, and consultants to develop appropriate statistical analysis methods
- Act as expert for data collection and acquisition, advising teams and stakeholders on best practices and proposing innovative solutions
- Manage the database implementation, including lock and close-out processes and procedures
- Prepare and present study data and reports for internal and external teams
- Create submission-ready study data packages per regulatory agency's requirements in collaboration with the Regulatory and Clinical Affairs team
- Collaborate with the Clinical Affairs team to ensure all study data is complete, timely, and accurate
- Provide leadership, mentoring, guidance, and support to the Data Coordinators, mentoring each in their job responsibilities
- Support routine internal data audits of projects
- Support the harmonization of data management processes between MDC project teams
- Create training materials for EDC users and provide project-specific training as required
- Identify and implement new hardware and software tools as needs arise
- Bachelor's degree in a data science or related discipline or educational equivalent
- 8-10 years of relevant experience in data analysis, statistics, and visualization
- 5+ years of experience leading projects and teams
- Biotech, CRO, or academic experience preferred
- Strong understanding of statistical analysis techniques (dispersion, confidence intervals, etc.)
- Competent with database creation, entry, scripting, and analysis using MS Access and MySQL
- Experience working with Electronic Data Capture (EDC) systems preferred
- Ability to interpret study protocols and internal procedures to meet database and output requirements
- Strong proficiency across the MS Office Suite of products
- Ability to manage competing priorities and drive initiatives without compromising quality
- Demonstrated ability to build rapport and effectively lead change efforts
- Demonstrated ability to solve problems and resolve conflicts independently and collaboratively
- Salary + Bonus/Profit Share
- Equity Incentive Plan Participation
- Medical, Dental, and Vision Insurance
- Flexible Spending / Dependent Care Accounts
- STD/LTD/GTL/VTL
- 401(k) w/ match
- Generous PTO / Sick time policy
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Lead Clinical Data Manager - Beverly, United States - MDC Associates LLC
3 weeks ago
Description
As a Lead Clinical Data Manager you will lead the development, implementation, and management of databases used in support of US FDA and ex-US Regulatory submissions of in vitro diagnostic devices. This new role will also oversee the data management team and be responsible for the coordination of data entry, reporting, and visualization. Join our fast-growing team as we scale up to meet the increasing demand of the medical diagnostics industry.
The ideal candidate will have proven experience in data management and analysis/reporting that includes informative data visualization tools. As the lead of the Data Management Team and a collaborator with internal stakeholders, this person will be detail-oriented, professional, and have confidence in preparing and proposing best practices and tools that will offer a best-in-class client experience . Previous experience and/or exposure to clinical protocols and/or clinical trial data is preferred.
Responsibilities
Qualifications
About MDC
For over 35 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients around the world. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Clinical Research services to help them launch new advances that promote and protect our communities' health. Learn more at
By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and know that our success is tied to your success. Take the next step to explore the opportunity with MDC by applying for this position.
Pay & Benefits:
Job Location: In-office, Beverly, MA, Remote-eligible
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